Colorectal Cancer Clinical Trial
Official title:
Phase II Trial of Fluorouracil (5-FU), Leucovorin (LV), Irinotecan (CPT-11) and Bevacizumab (Anti-VEGF) in Previously Untreated Patients With Advanced Colorectal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Bevacizumab may stop the growth of colorectal cancer by
stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus
bevacizumab in treating patients who have advanced colorectal cancer.
OBJECTIVES: I. Determine the progression-free survival at 7 months of patients with
previously untreated advanced colorectal cancer treated with fluorouracil, leucovorin
calcium, irinotecan, and bevacizumab. II. Determine the response rate and overall survival
of this patient population treated with this regimen. III. Determine the toxicity of this
treatment regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive irinotecan IV over 90 minutes,
leucovorin calcium IV, and fluorouracil IV once weekly for 4 weeks. Patients also receive
bevacizumab IV over 30-90 minutes once every 2 weeks. Treatment repeats every 6 weeks in the
absence of disease progression or unacceptable toxicity. Patients are followed every 3
months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 1 year.
;
Primary Purpose: Treatment
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