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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (complete or partial response) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST)
Up to 7 years
No
Hedy Kindler
Principal Investigator
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
NCI-2012-02622
NCT00091026
July 2004
Name | Location |
---|---|
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |