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)
- Determine the efficacy of irinotecan and docetaxel with or without cetuximab, in terms
of objective response rate, in patients with metastatic adenocarcinoma of the pancreas.
- Determine the time to progression and overall survival of patients treated with these
- Determine the proportion of patients with tumors that overexpress epidermal growth
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
- Arm A: Patients receive docetaxel IV over 1 hour and irinotecan IV over 30 minutes
weekly on days 1, 8, 15, and 22.
- Arm B: Patients receive docetaxel and irinotecan as in arm A. Patients also receive
cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36.
Courses repeat in both arms every 6 weeks in the absence of disease progression or
Patients are followed every 3 months for 2 years, every 6 months for 1 year, and then
PROJECTED ACCRUAL: A total of 92 patients (46 per treatment arm)
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of Patients With Objective Response Evaluated by RECIST (Solid Tumor Response Criteria)
Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR
Assessed every 12 weeks until progression
Barbara A. Burtness, MD
Fox Chase Cancer Center
United States: Federal Government