Stage IV Pancreatic Cancer Clinical Trial
Official title:
A Randomized Phase II Study of Bevacizumab (NSC# 704865) and Gemcitabine in Combination With Either Cetuximab (NSC# 714692) or OSI-774 (NSC# 718781) in Patients With Advanced Pancreatic Cancer
This randomized phase II trial is studying bevacizumab, gemcitabine, and cetuximab to see how well they work compared to bevacizumab, gemcitabine, and erlotinib in treating patients with advanced pancreatic cancer. Monoclonal antibodies, such as cetuximab and bevacizumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining bevacizumab and gemcitabine with either cetuximab or erlotinib may kill more tumor cells.
OBJECTIVES:
I. Compare the objective response rate in patients with advanced adenocarcinoma of the
pancreas treated with bevacizumab and gemcitabine with cetuximab vs erlotinib.
II. Compare the toxicity of these regimens in these patients. III. Compare median
progression-free and overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center (University of Chicago vs other) and ECOG performance status (0-1 vs
2). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV
over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and
15.
Arm II: Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral
erlotinib once daily on days 1-5, 8-12, and 15-26.
In both arms, courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 54-126 patients (27-63 per treatment arm) will be accrued for
this study within 16 months.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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