G-CSF in Preventing Neutropenia During First-Line Treatment With Chemotherapy and Bevacizumab in Patients With Metastatic Colorectal Cancer

OBJECTIVES: Primary * Determine if primary prophylaxis comprising filgrastim (G-CSF) makes it possible to obtain neutropenia lower than grade 4 or a 30% decrease in fever in patients with metastatic colorectal cancer receiving first-line FOLFIRI and bevacizumab and who are homozygous for allele UGT1A1\*28 (genotype 7/7), a promoter of the gene coding for enzyme UGT1A1. Secondary * Evaluate the objective response rate at 6 months of treatment with FOLFIRI and bevacizumab according to RECIST criteria. * Evaluate the toxicity (excluding neutropenia) of FOLFIRI and bevacizumab according to NCI-CTC v. 2.0. * Determine progression-free and overall survival. * Determine the time to treatment failure. OUTLINE: This is a multicenter study. 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. Patients also receive filgrastim (G-CSF) subcutaneously on days 5-11. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed every 2-3 months for up to 5 years.