Combination Chemotherapy and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer

OBJECTIVES: Primary * Evaluate the objective response (RECIST criteria) at 6 months associated with FOLFIRI and bevacizumab therapy. * Evaluate the tolerability (NCI CTC v. 2.0 criteria) of this treatment. Secondary * Evaluate progression-free survival and overall survival. * Determine the time to treatment failure. * Evaluate the quality of life (EuroQOL EQ5D questionnaire). * Explore the prognostic factors associated with the tolerability and efficacy of this treatment. OUTLINE: This is a multicenter study. Patients are stratified according to genotype (UCT1A1\*1/ UCT1A1\*1 vs UCT1A1\*1/ UCT1A1\*28). Patients receive bevacizumab IV over 30-90 minutes, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 4 courses, and then every 2 months after the completion of study therapy. After completion of study therapy, patients are followed every 2-3 months.