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Irinotecan and Docetaxel With or Without Cetuximab in Treating Patients With Metastatic Pancreatic Cancer
This study has been completed.
Study NCT00042939   Information provided by Eastern Cooperative Oncology Group

First Received on August 5, 2002.   Last Updated on June 21, 2011   History of Changes
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
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Reporting Groups
  Description
Arm A: Irinotecan/Docetaxel No text entered.
Arm B: Irinotecan/Docetaxel/Cetuximab No text entered.

Participant Flow:   Overall Study
    Arm A: Irinotecan/Docetaxel     Arm B: Irinotecan/Docetaxel/Cetuximab  
STARTED     48     46  
Eligible and Began Protocol Therapy     44     43  
COMPLETED     24     23  
NOT COMPLETED     24     23  
Adverse Event                 6                 7  
Death                 3                 2  
Withdrawal by Subject                 5                 4  
Other disease                 1                 0  
Ineligible                 2                 2  
Other                 7                 8  



  Baseline Characteristics
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Reporting Groups
  Description
Arm A: Irinotecan/Docetaxel No text entered.
Arm B: Irinotecan/Docetaxel/Cetuximab No text entered.

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
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1.  Primary:   Response Rate by RECIST   [ Time Frame: Assessed every 12 weeks until progression ]
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2.  Secondary:   Progression-free Survival   [ Time Frame: Assessed every 3 months for 2 years and then every 6 months for 1 year ]
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3.  Secondary:   Overall Survival   [ Time Frame: Assessed every 3 months for 2 years and then every 6 months for 1 year ]
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4.  Secondary:   Epidermal Growth Factor Receptor (EGFR) Status   [ Time Frame: Original tumor tissue samples submitted within one month of patient randomization ]
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5.  Secondary:   Rate of Thromboembolic Events   [ Time Frame: Assessed every 6 weeks while on treatment and for 30 days after the end of treatment ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


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
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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: Robert L. Comis, ECOG Group Chair's Office
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: June 21, 2011
Health Authority: United States: Federal Government;   United States: Food and Drug Administration





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