Spots Global Cancer Trial Database for G-CSF in Preventing Neutropenia During First-Line Treatment With Chemotherapy and Bevacizumab in Patients With Metastatic Colorectal Cancer

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Trial Identification

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

Official Title: Phase II, Multicenter Study Evaluating G-CSF as Primary Prophylaxis for Neutropenia Associated With First-line Chemotherapy Regimen FOLFIRI and Bevacizumab in Patients With Metastatic Colorectal Cancer Who Are Homozygous for UGT1A1*28 Polymorphism, the Promoter of the Gene Encoding for the Enzyme UGT1A1

Study ID: NCT00541125

Conditions

Colorectal Cancer

Interventions

bevacizumab

filgrastim

fluorouracil

irinotecan hydrochloride

leucovorin calcium

Study Description

Brief Summary: RATIONALE: G-CSF may prevent or control neutropenia caused by first-line therapy in patients with metastatic colorectal cancer. PURPOSE: This phase II trial is studying how well G-CSF works in preventing neutropenia during first-line treatment with chemotherapy and bevacizumab in patients with metastatic colorectal cancer.

Detailed Description: 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.