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Cetuximab and Bevacizumab With or Without Gemcitabine to Treat Metastatic Pancreatic Cancer

This study has been terminated.
(The planned enrollment was 130 patients and the study was halted prematurely due to lack of efficacy in both arms. Enrolled patients continued treatment.)
Sponsor:
Information provided by:
ImClone LLC
ClinicalTrials.gov Identifier:
NCT00326911
First received: May 15, 2006
Last updated: May 19, 2011
Last verified: May 2011
History of Changes
Results First Received: November 3, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Pancreatic Cancer
Interventions: Biological: cetuximab
Biological: bevacizumab
Drug: gemcitabine

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from a population of pancreatic cancer patients treated at investigational centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior chemotherapy, hormonal therapy, radiation therapy in the adjuvant setting were allowed, provided that the last date of therapy was at least 6 months prior to randomization.

Reporting Groups
  Description
Cetuximab + Bevacizumab + Gemcitabine Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab + Bevacizumab Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Participant Flow:   Overall Study
    Cetuximab + Bevacizumab + Gemcitabine     Cetuximab + Bevacizumab  
STARTED     30 [1]   31 [1]
COMPLETED     29 [2]   29 [2]
NOT COMPLETED     1     2  
Hospitalization prior to treatment                 0                 1  
Physician decision prior to treatment                 1                 0  
Withdrawal by subject prior to treatment                 0                 1  
[1] This number reflects all randomized patients.
[2] This number reflects all treated patients.



  Baseline Characteristics
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Reporting Groups
  Description
Cetuximab + Bevacizumab + Gemcitabine Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab + Bevacizumab Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Total Total of all reporting groups

Baseline Measures
    Cetuximab + Bevacizumab + Gemcitabine     Cetuximab + Bevacizumab     Total  
Number of Participants  
[units: participants]
 		  30     31     61  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     18     18     36  
>=65 years     12     13     25  
Age  
[units: years]
Mean ± Standard Deviation 		  62.7  ± 11.6     62.2  ± 11.4     62.4  ± 11.4  
Gender  
[units: participants]
 		     
Female     11     15     26  
Male     19     16     35  
Region of Enrollment  
[units: participants]
 		     
United States     30     31     61  



  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: Time from randomization to disease progression or death from any cause (Range: 0 -10 months) ]

Measure Type Primary
Measure Title Progression-free Survival (PFS)
Measure Description Progression-free survival is the time from randomization until the date of progressive disease (PD) or death from any cause whichever is first reported. Patients who die without a reported prior progression were considered to have progresssed on the day of their death. Patients who did not progress were censored at the day of their last tumor assessment.
Time Frame Time from randomization to disease progression or death from any cause (Range: 0 -10 months)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PFS was based on the modified Intent-to-Treat (mITT) population, which included any patient who enrolled, was randomized, and received any quantity of study drug.

Reporting Groups
  Description
Cetuximab + Bevacizumab + Gemcitabine Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab + Bevacizumab Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Measured Values
    Cetuximab + Bevacizumab + Gemcitabine     Cetuximab + Bevacizumab  
Number of Participants Analyzed  
[units: participants]
 		  29     29  
Progression-free Survival (PFS)  
[units: months]
Median ( 95% Confidence Interval ) 		  3.55  
  ( 2.00 to 5.59 )   		  1.91  
  ( 1.81 to 2.76 )  

No statistical analysis provided for Progression-free Survival (PFS)



2.  Secondary:   Overall Survival (OS)   [ Time Frame: Survival information was collected continuously every 3 months after completion of therapy and/or follow-up (range: 1-19 months). ]

Measure Type Secondary
Measure Title Overall Survival (OS)
Measure Description This measure is defined as the time from randomization to the date of death due to any cause. Survival of living patients or those who lost to follow-up were censored on the last date the patients were known to be alive.
Time Frame Survival information was collected continuously every 3 months after completion of therapy and/or follow-up (range: 1-19 months).  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The overall survival was based on the mITT population.

Reporting Groups
  Description
Cetuximab + Bevacizumab + Gemcitabine Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab + Bevacizumab Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Measured Values
    Cetuximab + Bevacizumab + Gemcitabine     Cetuximab + Bevacizumab  
Number of Participants Analyzed  
[units: participants]
 		  29     29  
Overall Survival (OS)  
[units: Months]
Median ( 95% Confidence Interval ) 		  5.41  
  ( 3.84 to 6.74 )   		  4.17  
  ( 2.69 to 8.74 )  

No statistical analysis provided for Overall Survival (OS)



3.  Secondary:   The Number of Patients With a Best Overall Response of Either a Complete Response (CR) or Partial Response (PR)   [ Time Frame: Tumor evaluations were performed every 8 weeks while on cetuximab therapy until PD or recurrence. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation. ]

Measure Type Secondary
Measure Title The Number of Patients With a Best Overall Response of Either a Complete Response (CR) or Partial Response (PR)
Measure Description The best overall response is the number of patients with a best overall response of CR or PR, as classifed by the investigator according to the RECIST guidelines. A CR is the disappearance of all target lesions and a PR is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.
Time Frame Tumor evaluations were performed every 8 weeks while on cetuximab therapy until PD or recurrence. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The best overall response was based on the mITT population for those patients who either had a CR or PR.

Reporting Groups
  Description
Cetuximab + Bevacizumab + Gemcitabine Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab + Bevacizumab Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Measured Values
    Cetuximab + Bevacizumab + Gemcitabine     Cetuximab + Bevacizumab  
Number of Participants Analyzed  
[units: participants]
 		  29     29  
The Number of Patients With a Best Overall Response of Either a Complete Response (CR) or Partial Response (PR)  
[units: Participants]
 		  4     0  

No statistical analysis provided for The Number of Patients With a Best Overall Response of Either a Complete Response (CR) or Partial Response (PR)



4.  Secondary:   Percentage of Patients With Carbohydrate Antigen 19-9 (CA19-9) Response at End of Cycle 2 in Patients With Elevated Baseline Values (Equal or Greater Than 2 x Upper Limit of Normal).   [ Time Frame: First day of treatment to the end of Cycle 2, Week 1 ]

Measure Type Secondary
Measure Title Percentage of Patients With Carbohydrate Antigen 19-9 (CA19-9) Response at End of Cycle 2 in Patients With Elevated Baseline Values (Equal or Greater Than 2 x Upper Limit of Normal).
Measure Description CA19-9 is a tumor marker for pancreatic cancer and the level usually increases as the disease is progressing. The CA19-9 response was the percentage of patients whose CA19-9 level was declining, stable or increasing < 10% compared with baseline, divided by the total patients with elevated baseline CA19-9 in that arm.
Time Frame First day of treatment to the end of Cycle 2, Week 1  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The CA19-9 response rate was calculated for at least the 15 patients in each arm of the study at the end of the first two cycles of therapy (8 weeks) in the mITT population who had elevated CA19-9 levels at baseline.

Reporting Groups
  Description
Cetuximab + Bevacizumab + Gemcitabine Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab + Bevacizumab Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Measured Values
    Cetuximab + Bevacizumab + Gemcitabine     Cetuximab + Bevacizumab  
Number of Participants Analyzed  
[units: participants]
 		  18     19  
Percentage of Patients With Carbohydrate Antigen 19-9 (CA19-9) Response at End of Cycle 2 in Patients With Elevated Baseline Values (Equal or Greater Than 2 x Upper Limit of Normal).  
[units: Percentage of participants]
 		  8     9  

No statistical analysis provided for Percentage of Patients With Carbohydrate Antigen 19-9 (CA19-9) Response at End of Cycle 2 in Patients With Elevated Baseline Values (Equal or Greater Than 2 x Upper Limit of Normal).



5.  Secondary:   Time to Progression (TTP)   [ Time Frame: Time from randomization until the date of objective tumor progression was first reported (range: 11 -38 months) ]

Measure Type Secondary
Measure Title Time to Progression (TTP)
Measure Description Time to progression was defined as the time from randomization until the date of objectively confirmed tumor progression was first reported. The censoring rule was consistent with PFS except death. Patients who died from any cause were censored at the time of death or at last tumor assessment date if the death date was missing. For patients lost to follow-up, they were censored at the last tumor assessment date.
Time Frame Time from randomization until the date of objective tumor progression was first reported (range: 11 -38 months)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The TTP was based on the mITT population. For patients lost to follow-up, they were censored at the next scheduled visit.

Reporting Groups
  Description
Cetuximab + Bevacizumab + Gemcitabine Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab + Bevacizumab Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Measured Values
    Cetuximab + Bevacizumab + Gemcitabine     Cetuximab + Bevacizumab  
Number of Participants Analyzed  
[units: participants]
 		  29     29  
Time to Progression (TTP)  
[units: months]
Median ( 95% Confidence Interval ) 		  4.11  
  ( 2.17 to 5.95 )   		  2.07  
  ( 1.84 to 4.01 )  

No statistical analysis provided for Time to Progression (TTP)



6.  Secondary:   Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: An AE was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab. ]

Measure Type Secondary
Measure Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measure Description Reported AEs per patient were coded according to the corresponding preferred term and system organ class in the Medical Dictionary for regulatory Activities dictionary. The National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 was used to grade all AEs. The collection of AEs began at the time the patient received the first cetuximab dose and continued during the study until 30 days after the last dose of cetuximab. All patients who were enrolled and treated with cetuximab were assessed for safety (mITT population, as treated).
Time Frame An AE was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab.  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who received any quantity of study therapy were included in the safety evaluation (safety population, as treated).

Reporting Groups
  Description
Cetuximab + Bevacizumab + Gemcitabine Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab + Bevacizumab Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Measured Values
    Cetuximab + Bevacizumab + Gemcitabine     Cetuximab + Bevacizumab  
Number of Participants Analyzed  
[units: participants]
 		  29     29  
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)  
[units: Participants]
 		  29     29  

No statistical analysis provided for Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)



7.  Secondary:   Change From Baseline in Quality of Life (QoL) Assessment Using the Linear Analog Scale Assessment (LASA), Overall QoL at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

Measure Type Secondary
Measure Title Change From Baseline in Quality of Life (QoL) Assessment Using the Linear Analog Scale Assessment (LASA), Overall QoL at Cycle 2 Week 4
Measure Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall QoL question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
mITT population

Reporting Groups
  Description
Cetuximab + Bevacizumab + Gemcitabine Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab + Bevacizumab Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Measured Values
    Cetuximab + Bevacizumab + Gemcitabine     Cetuximab + Bevacizumab  
Number of Participants Analyzed  
[units: participants]
 		  17     12  
Change From Baseline in Quality of Life (QoL) Assessment Using the Linear Analog Scale Assessment (LASA), Overall QoL at Cycle 2 Week 4  
[units: Scores on a scale]
Mean ± Standard Deviation 		  -0.9  ± 2.9     -0.9  ± 2.3  

No statistical analysis provided for Change From Baseline in Quality of Life (QoL) Assessment Using the Linear Analog Scale Assessment (LASA), Overall QoL at Cycle 2 Week 4



8.  Secondary:   Change From Baseline in QoL Assessment Using LASA, Overall Mental Well Being, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

Measure Type Secondary
Measure Title Change From Baseline in QoL Assessment Using LASA, Overall Mental Well Being, at Cycle 2 Week 4
Measure Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Mental Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
mITT population

Reporting Groups
  Description
Cetuximab + Bevacizumab + Gemcitabine Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab + Bevacizumab Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Measured Values
    Cetuximab + Bevacizumab + Gemcitabine     Cetuximab + Bevacizumab  
Number of Participants Analyzed  
[units: participants]
 		  17     11  
Change From Baseline in QoL Assessment Using LASA, Overall Mental Well Being, at Cycle 2 Week 4  
[units: Scores on a scale]
Mean ± Standard Deviation 		  0.6  ± 2.0     -0.8  ± 1.4  

No statistical analysis provided for Change From Baseline in QoL Assessment Using LASA, Overall Mental Well Being, at Cycle 2 Week 4



9.  Secondary:   Change From Baseline in QoL Assessment Using LASA, Overall Physical Well Being, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

Measure Type Secondary
Measure Title Change From Baseline in QoL Assessment Using LASA, Overall Physical Well Being, at Cycle 2 Week 4
Measure Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Physical Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
mITT population

Reporting Groups
  Description
Cetuximab + Bevacizumab + Gemcitabine Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab + Bevacizumab Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Measured Values
    Cetuximab + Bevacizumab + Gemcitabine     Cetuximab + Bevacizumab  
Number of Participants Analyzed  
[units: participants]
 		  17     12  
Change From Baseline in QoL Assessment Using LASA, Overall Physical Well Being, at Cycle 2 Week 4  
[units: Scores on a scale]
Mean ± Standard Deviation 		  -0.6  ± 3.1     -0.6  ± 1.7  

No statistical analysis provided for Change From Baseline in QoL Assessment Using LASA, Overall Physical Well Being, at Cycle 2 Week 4



10.  Secondary:   Change From Baseline in QoL Assessment Using LASA, Overall Emotional Well Being, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

Measure Type Secondary
Measure Title Change From Baseline in QoL Assessment Using LASA, Overall Emotional Well Being, at Cycle 2 Week 4
Measure Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Emotional Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
mITT Population

Reporting Groups
  Description
Cetuximab + Bevacizumab + Gemcitabine Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab + Bevacizumab Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Measured Values
    Cetuximab + Bevacizumab + Gemcitabine     Cetuximab + Bevacizumab  
Number of Participants Analyzed  
[units: participants]
 		  17     11  
Change From Baseline in QoL Assessment Using LASA, Overall Emotional Well Being, at Cycle 2 Week 4  
[units: Scores on a scale]
Mean ± Standard Deviation 		  -0.2  ± 2.8     -1.1  ± 2.1  

No statistical analysis provided for Change From Baseline in QoL Assessment Using LASA, Overall Emotional Well Being, at Cycle 2 Week 4



11.  Secondary:   Change From Baseline in QoL Assessment Using LASA, Level of Social Activity, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

Measure Type Secondary
Measure Title Change From Baseline in QoL Assessment Using LASA, Level of Social Activity, at Cycle 2 Week 4
Measure Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Level of Social Activity question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
mITT population

Reporting Groups
  Description
Cetuximab + Bevacizumab + Gemcitabine Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab + Bevacizumab Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Measured Values
    Cetuximab + Bevacizumab + Gemcitabine     Cetuximab + Bevacizumab  
Number of Participants Analyzed  
[units: participants]
 		  17     12  
Change From Baseline in QoL Assessment Using LASA, Level of Social Activity, at Cycle 2 Week 4  
[units: Scores on a scale]
Mean ± Standard Deviation 		  -1.1  ± 2.9     0.6  ± 2.3  

No statistical analysis provided for Change From Baseline in QoL Assessment Using LASA, Level of Social Activity, at Cycle 2 Week 4



12.  Secondary:   Change From Baseline in QoL Assessment Using LASA, Overall Spiritual Well Being, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up while receiving study drug ]

Measure Type Secondary
Measure Title Change From Baseline in QoL Assessment Using LASA, Overall Spiritual Well Being, at Cycle 2 Week 4
Measure Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Spiritual Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up while receiving study drug  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
mITT population

Reporting Groups
  Description
Cetuximab + Bevacizumab + Gemcitabine Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab + Bevacizumab Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Measured Values
    Cetuximab + Bevacizumab + Gemcitabine     Cetuximab + Bevacizumab  
Number of Participants Analyzed  
[units: participants]
 		  17     11  
Change From Baseline in QoL Assessment Using LASA, Overall Spiritual Well Being, at Cycle 2 Week 4  
[units: Scores on a scale]
Mean ± Standard Deviation 		  -0.4  ± 1.8     -0.3  ± 1.1  

No statistical analysis provided for Change From Baseline in QoL Assessment Using LASA, Overall Spiritual Well Being, at Cycle 2 Week 4



13.  Secondary:   Change From Baseline in QoL Assessment Using LASA, Frequency of Pain, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

Measure Type Secondary
Measure Title Change From Baseline in QoL Assessment Using LASA, Frequency of Pain, at Cycle 2 Week 4
Measure Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Frequency of Pain question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates improvement from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
mITT population

Reporting Groups
  Description
Cetuximab + Bevacizumab + Gemcitabine Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab + Bevacizumab Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Measured Values
    Cetuximab + Bevacizumab + Gemcitabine     Cetuximab + Bevacizumab  
Number of Participants Analyzed  
[units: participants]
 		  17     12  
Change From Baseline in QoL Assessment Using LASA, Frequency of Pain, at Cycle 2 Week 4  
[units: Scores on a scale]
Mean ± Standard Deviation 		  -1.5  ± 2.9     -2.3  ± 2.6  

No statistical analysis provided for Change From Baseline in QoL Assessment Using LASA, Frequency of Pain, at Cycle 2 Week 4



14.  Secondary:   Change From Baseline in QoL Assessment Using LASA, Severity of Pain, Average, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up while receiving study drug ]

Measure Type Secondary
Measure Title Change From Baseline in QoL Assessment Using LASA, Severity of Pain, Average, at Cycle 2 Week 4
Measure Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Severity of Pain question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A positive score indicates improvement from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up while receiving study drug  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
mITT population

Reporting Groups
  Description
Cetuximab + Bevacizumab + Gemcitabine Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab + Bevacizumab Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Measured Values
    Cetuximab + Bevacizumab + Gemcitabine     Cetuximab + Bevacizumab  
Number of Participants Analyzed  
[units: participants]
 		  17     12  
Change From Baseline in QoL Assessment Using LASA, Severity of Pain, Average, at Cycle 2 Week 4  
[units: Scores on a scale]
Mean ± Standard Deviation 		  -0.5  ± 2.8     -0.9  ± 2.4  

No statistical analysis provided for Change From Baseline in QoL Assessment Using LASA, Severity of Pain, Average, at Cycle 2 Week 4



15.  Secondary:   Change From Baseline in QoL Assessment Using LASA, Level of Fatigue, Average, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

Measure Type Secondary
Measure Title Change From Baseline in QoL Assessment Using LASA, Level of Fatigue, Average, at Cycle 2 Week 4
Measure Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Level of Fatigue question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A positive score indicates improvement from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
mITT Population

Reporting Groups
  Description
Cetuximab + Bevacizumab + Gemcitabine Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab + Bevacizumab Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Measured Values
    Cetuximab + Bevacizumab + Gemcitabine     Cetuximab + Bevacizumab  
Number of Participants Analyzed  
[units: participants]
 		  17     12  
Change From Baseline in QoL Assessment Using LASA, Level of Fatigue, Average, at Cycle 2 Week 4  
[units: Scores on a scale]
Mean ± Standard Deviation 		  1.5  ± 2.3     0.3  ± 2.6  

No statistical analysis provided for Change From Baseline in QoL Assessment Using LASA, Level of Fatigue, Average, at Cycle 2 Week 4



16.  Secondary:   Change From Baseline in QoL Assessment Using LASA, Level of Support, Friends and Family, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

Measure Type Secondary
Measure Title Change From Baseline in QoL Assessment Using LASA, Level of Support, Friends and Family, at Cycle 2 Week 4
Measure Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Level of Support, Friends and Family question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
mITT Population

Reporting Groups
  Description
Cetuximab + Bevacizumab + Gemcitabine Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab + Bevacizumab Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Measured Values
    Cetuximab + Bevacizumab + Gemcitabine     Cetuximab + Bevacizumab  
Number of Participants Analyzed  
[units: participants]
 		  17     12  
Change From Baseline in QoL Assessment Using LASA, Level of Support, Friends and Family, at Cycle 2 Week 4  
[units: Scores on a scale]
Mean ± Standard Deviation 		  0.1  ± 1.3     -0.8  ± 1.5  

No statistical analysis provided for Change From Baseline in QoL Assessment Using LASA, Level of Support, Friends and Family, at Cycle 2 Week 4



17.  Secondary:   Change From Baseline in QoL Assessment Using LASA, Financial Concerns, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

Measure Type Secondary
Measure Title Change From Baseline in QoL Assessment Using LASA, Financial Concerns, at Cycle 2 Week 4
Measure Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Financial Concerns Question question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
mITT population

Reporting Groups
  Description
Cetuximab + Bevacizumab + Gemcitabine Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab + Bevacizumab Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Measured Values
    Cetuximab + Bevacizumab + Gemcitabine     Cetuximab + Bevacizumab  
Number of Participants Analyzed  
[units: participants]
 		  17     12  
Change From Baseline in QoL Assessment Using LASA, Financial Concerns, at Cycle 2 Week 4  
[units: Scores on a scale]
Mean ± Standard Deviation 		  -0.1  ± 2.4     0.9  ± 3.7  

No statistical analysis provided for Change From Baseline in QoL Assessment Using LASA, Financial Concerns, at Cycle 2 Week 4



18.  Secondary:   Change From Baseline in QoL Assessment Using LASA, Legal Concerns, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

Measure Type Secondary
Measure Title Change From Baseline in QoL Assessment Using LASA, Legal Concerns, at Cycle 2 Week 4
Measure Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Legal Concerns question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
mITT population

Reporting Groups
  Description
Cetuximab + Bevacizumab + Gemcitabine Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab + Bevacizumab Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Measured Values
    Cetuximab + Bevacizumab + Gemcitabine     Cetuximab + Bevacizumab  
Number of Participants Analyzed  
[units: participants]
 		  17     12  
Change From Baseline in QoL Assessment Using LASA, Legal Concerns, at Cycle 2 Week 4  
[units: Scores on a scale]
Mean ± Standard Deviation 		  0.4  ± 1.7     2.3  ± 3.2  

No statistical analysis provided for Change From Baseline in QoL Assessment Using LASA, Legal Concerns, at Cycle 2 Week 4



19.  Secondary:   Change From Baseline in Assessment of Pain Using the Brief Pain Inventory (BPI) Short Form, Worst Pain, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

Measure Type Secondary
Measure Title Change From Baseline in Assessment of Pain Using the Brief Pain Inventory (BPI) Short Form, Worst Pain, at Cycle 2 Week 4
Measure Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Worst Pain (change from baseline) to Cycle 2 Week 4 is reported. The worst pain is 10 and no pain is 0. A negative score indicates improvement from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
mITT population

Reporting Groups
  Description
Cetuximab + Bevacizumab + Gemcitabine Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab + Bevacizumab Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Measured Values
    Cetuximab + Bevacizumab + Gemcitabine     Cetuximab + Bevacizumab  
Number of Participants Analyzed  
[units: participants]
 		  17     12  
Change From Baseline in Assessment of Pain Using the Brief Pain Inventory (BPI) Short Form, Worst Pain, at Cycle 2 Week 4  
[units: Scores on a scale]
Mean ± Standard Deviation 		  -1.2  ± 2.8     0.5  ± 2.5  

No statistical analysis provided for Change From Baseline in Assessment of Pain Using the Brief Pain Inventory (BPI) Short Form, Worst Pain, at Cycle 2 Week 4



20.  Secondary:   Change From Baseline in Assessment of Pain Using BPI Short Form, Least Pain, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

Measure Type Secondary
Measure Title Change From Baseline in Assessment of Pain Using BPI Short Form, Least Pain, at Cycle 2 Week 4
Measure Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Least Pain (change from baseline) to Cycle 2 Week 4 is reported. The worst pain is 10 and no pain is 0. A negative score indicates improvement from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
mITT population

Reporting Groups
  Description
Cetuximab + Bevacizumab + Gemcitabine Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab + Bevacizumab Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Measured Values
    Cetuximab + Bevacizumab + Gemcitabine     Cetuximab + Bevacizumab  
Number of Participants Analyzed  
[units: participants]
 		  17     12  
Change From Baseline in Assessment of Pain Using BPI Short Form, Least Pain, at Cycle 2 Week 4  
[units: Scores on a scale]
Mean ± Standard Deviation 		  -0.4  ± 2.0     0.9  ± 2.4  

No statistical analysis provided for Change From Baseline in Assessment of Pain Using BPI Short Form, Least Pain, at Cycle 2 Week 4



21.  Secondary:   Change From Baseline in Assessment of Pain Using BPI Short Form, Average Pain, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

Measure Type Secondary
Measure Title Change From Baseline in Assessment of Pain Using BPI Short Form, Average Pain, at Cycle 2 Week 4
Measure Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Average Pain (change from baseline) to Cycle 2 Week 4 is reported. The worst pain was 10 and no pain is 0. A negative score indicates improvement from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
mITT population

Reporting Groups
  Description
Cetuximab + Bevacizumab + Gemcitabine Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab + Bevacizumab Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Measured Values
    Cetuximab + Bevacizumab + Gemcitabine     Cetuximab + Bevacizumab  
Number of Participants Analyzed  
[units: participants]
 		  17     12  
Change From Baseline in Assessment of Pain Using BPI Short Form, Average Pain, at Cycle 2 Week 4  
[units: Scores on a scale]
Mean ± Standard Deviation 		  -0.6  ± 1.8     -0.2  ± 2.1  

No statistical analysis provided for Change From Baseline in Assessment of Pain Using BPI Short Form, Average Pain, at Cycle 2 Week 4



22.  Secondary:   Change From Baseline in Assessment of Pain Using BPI Short Form, Pain Right Now, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

Measure Type Secondary
Measure Title Change From Baseline in Assessment of Pain Using BPI Short Form, Pain Right Now, at Cycle 2 Week 4
Measure Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Pain Right Now question (change from baseline) to Cycle 2 Week 4 is reported. The worst pain is 10 and no pain is 0. A negative score indicates improvement from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
mITT population

Reporting Groups
  Description
Cetuximab + Bevacizumab + Gemcitabine Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab + Bevacizumab Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Measured Values
    Cetuximab + Bevacizumab + Gemcitabine     Cetuximab + Bevacizumab  
Number of Participants Analyzed  
[units: participants]
 		  17     12  
Change From Baseline in Assessment of Pain Using BPI Short Form, Pain Right Now, at Cycle 2 Week 4  
[units: Scores on a scale]
Mean ± Standard Deviation 		  -0.9  ± 2.6     0.9  ± 2.0  

No statistical analysis provided for Change From Baseline in Assessment of Pain Using BPI Short Form, Pain Right Now, at Cycle 2 Week 4



23.  Secondary:   Change From Baseline in Assessment of Pain Using BPI Short Form, Interference, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

Measure Type Secondary
Measure Title Change From Baseline in Assessment of Pain Using BPI Short Form, Interference, at Cycle 2 Week 4
Measure Description Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Interference question (change from baseline) to Cycle 2 Week 4 is reported. Complete interference is scored as 10 and no interference is scored as 0. A negative score indicates improvement from baseline.
Time Frame Screening, and then every 8 weeks while receiving study drug to 30-day follow-up  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
mITT population

Reporting Groups
  Description
Cetuximab + Bevacizumab + Gemcitabine Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab + Bevacizumab Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Measured Values
    Cetuximab + Bevacizumab + Gemcitabine     Cetuximab + Bevacizumab  
Number of Participants Analyzed  
[units: participants]
 		  16     12  
Change From Baseline in Assessment of Pain Using BPI Short Form, Interference, at Cycle 2 Week 4  
[units: Scores on a scale]
Mean ± Standard Deviation 		  -0.2  ± 2.3     0.8  ± 2.9  

No statistical analysis provided for Change From Baseline in Assessment of Pain Using BPI Short Form, Interference, at Cycle 2 Week 4




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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Accrual on the trial was stopped earlier than planned due to insufficient efficacy in both arms.  


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: ImClone LLC
e-mail: ClinicalTrials@ImClone.com


No publications provided by ImClone LLC

Publications automatically indexed to this study:


Responsible Party: Chief Medical Officer, ImClone LLC
ClinicalTrials.gov Identifier: NCT00326911     History of Changes
Other Study ID Numbers: CP02-0555
Study First Received: May 15, 2006
Results First Received: November 3, 2009
Last Updated: May 19, 2011
Health Authority: United States: Food and Drug Administration