Phase III Trial of Bevacizumab (NSC 704865), Oxaliplatin (NSC 266046), Fluorouracil and Leucovorin Versus Oxaliplatin, Fluorouracil and Leucovorin Versus Bevacizumab Alone in Previously Treated Patients With Advanced Colorectal Cancer
I. Compare the response, time to progression, and overall survival of patients with
previously treated advanced or metastatic colorectal adenocarcinoma treated with
oxaliplatin, leucovorin calcium, and fluorouracil with or without bevacizumab versus
bevacizumab only. (Arm III closed to accrual as of 03/11/2003).
II. Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to ECOG performance
status (0 vs 1 or 2), and prior radiotherapy (yes vs no). Patients are randomized to 1 of 3
Arm I: Patients receive bevacizumab IV over 30-90 minutes and oxaliplatin IV over 2 hours
on day 1. Patients also receive leucovorin calcium IV over 2 hours and fluorouracil (5-FU)
IV over 22 hours on days 1 and 2.
Arm II: Patients receive oxaliplatin, leucovorin calcium, and 5-FU as in arm I.
Arm III: Patients receive bevacizumab as in arm I. (Arm closed to accrual as of
Courses in all arms repeat every 2 weeks in the absence of disease progression or
unacceptable toxicity. Patients who achieve a complete response may receive 2 additional
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
From the date of entry on study, assessed up to 5 years
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
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