Recurrent Rectal Cancer Clinical Trial
Official title:
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
Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without bevacizumab in treating patients who have advanced or metastatic colorectal cancer that has been previously treated. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with combination chemotherapy may kill more tumor cells. It is not yet known if bevacizumab is more effective with or without combination chemotherapy in treating colorectal cancer
OBJECTIVES:
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
treatment arms.
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 03/11/2003).
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
courses.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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