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
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
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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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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.
No text entered.

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) ]

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). ]

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. ]

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 ]

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) ]

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. ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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