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
- 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
- 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.
Primary Purpose: Supportive Care
Rate of neutropenia grade 4 or fever
Thierry Lecomte, MD
CHRU de Tours - Hopital Trousseau