Phase II Study Evaluating the Association of Bevacizumab and Chemotherapy of the Type Modified FOLFIRI 3 in Patients With Metastatic Colorectal Adenocarcinoma
- Evaluate the objective response (complete and partial) rate in patients with metastatic
colorectal adenocarcinoma treated with bevacizumab and modified FOLFIRI 3 chemotherapy.
- Determine progression-free and overall survival.
- Determine the tolerance to this regimen.
- Evaluate the resectability rate.
- Evaluate biological markers predictive of the efficacy of this regimen.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on day 1, irinotecan hydrochloride IV
over 90 minutes on days 1 and 3, and fluorouracil IV continuously over 46 hours on day 1.
Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression
or unacceptable toxicity.
At 14 days after completing chemotherapy, patients with progressive or stable disease
receive maintenance therapy comprising bevacizumab and capecitabine.
Biological specimens are collected at baseline and before the fourth course of chemotherapy.
After completion of study therapy, patients are followed every 3 months for 2 years.
Allocation: Non-Randomized, Primary Purpose: Treatment
Objective response (complete and partial) rate
Christophe Borg, PhD
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz