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Irinotecan and Docetaxel With or Without Cetuximab in Treating Patients With Metastatic Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00042939
First received: August 5, 2002
Last updated: April 2, 2013
Last verified: December 2012
Results First Received: June 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pancreatic Cancer
Interventions: Biological: cetuximab
Drug: docetaxel
Drug: irinotecan hydrochloride

  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
E8200 opened to accrual on 7/31/2003 and was suspended on 12/2/2004 for evaluation of response and toxicity. Arm B was reactivated on 7/12/2005 after meeting the response criteria; Arm A was reactivated on 11/23/2005. Arm B and Arm A closed to accrual on 4/17/2006 and 8/23/2006, respectively, after meeting the accrual goal.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm A: Irinotecan/Docetaxel

Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².

Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles.

Arm B: Irinotecan/Docetaxel/Cetuximab

Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.

On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².

Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks.


Participant Flow:   Overall Study
    Arm A: Irinotecan/Docetaxel     Arm B: Irinotecan/Docetaxel/Cetuximab  
STARTED     48     46  
Treated     46     45  
Eligible and Began Protocol Therapy     44     43  
Patients With EGFR Results Available     30     31  
COMPLETED     24     25  
NOT COMPLETED     24     21  
Adverse Event                 6                 7  
Death                 3                 2  
Withdrawal by Subject                 3                 4  
Other disease                 1                 0  
Ineligible                 2                 2  
Deterioration of health                 3                 4  
QOL diminished                 1                 0  
Rising ca 19-9                 1                 0  
Patient non-compliance                 1                 0  
Still on treatment                 1                 0  
Treatment break > 4 weeks                 0                 1  
Did not start treatment                 2                 1  



  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
Arm A: Irinotecan/Docetaxel

Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².

Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles.

Arm B: Irinotecan/Docetaxel/Cetuximab

Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.

On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².

Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks.

Total Total of all reporting groups

Baseline Measures
    Arm A: Irinotecan/Docetaxel     Arm B: Irinotecan/Docetaxel/Cetuximab     Total  
Number of Participants  
[units: participants]
  44     43     87  
Age [1]
[units: years]
Median ( Full Range )
  60.2  
  ( 41.0 to 77.1 )  
  60.6  
  ( 41.0 to 74.2 )  
  60.4  
  ( 41.0 to 77.1 )  
Gender [2]
[units: participants]
     
Female     20     6     26  
Male     24     37     61  
[1] Age of eligible patients who began treatment.
[2] Gender of eligible patients who began treatment.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Patients With Objective Response Evaluated by RECIST (Solid Tumor Response Criteria)   [ Time Frame: Assessed every 12 weeks until progression ]

2.  Secondary:   Progression-free Survival   [ Time Frame: Assessed every 3 months for 2 years and then every 6 months for 1 year ]

3.  Secondary:   Overall Survival   [ Time Frame: Assessed every 3 months for 2 years and then every 6 months for 1 year ]

4.  Secondary:   Epidermal Growth Factor Receptor (EGFR) Status   [ Time Frame: Original tumor tissue samples submitted within one month of patient randomization ]

5.  Secondary:   Proportion of Patients With Thromboembolic Events   [ Time Frame: Assessed every 6 weeks while on treatment and for 30 days after the end of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: ECOG Statistical Office
phone: 617-632-3012


Publications of Results:
Burtness BA, Powell ME, Berlin JD, et al.: Phase II ECOG trial of irinotecan/docetaxel with or without cetuximab in metastatic pancreatic cancer: updated survival and CA19-9 results. [Abstract] J Clin Oncol 26 (Suppl 15): A-4642, 2008.
Burtness BA, Powell M, Berlin J, et al.: Phase II trial of irinotecan/docetaxel for advanced pancreatic cancer with randomization between irinotecan/docetaxel and irinotecan/docetaxel plus C225, a monoclonal antibody to the epidermal growth factor receptor (EGF-r) : Eastern Cooperative Oncology. [Abstract] J Clin Oncol 25 (Suppl 18): A-4519, 2007.


Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00042939     History of Changes
Other Study ID Numbers: CDR0000069486, U10CA021115, E8200 [ECOG]
Study First Received: August 5, 2002
Results First Received: June 21, 2011
Last Updated: April 2, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration