NCT00544011

Bevacizumab and Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

Phase II Study Evaluating the Association of Bevacizumab and Chemotherapy of the Type Modified FOLFIRI 3 in Patients With Metastatic Colorectal Adenocarcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sponsor: Hopital Jean Minjoz · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as irinotecan, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well bevacizumab given together with combination chemotherapy works in treating patients with metastatic colorectal cancer.

Detailed description

OBJECTIVES: Primary * Evaluate the objective response (complete and partial) rate in patients with metastatic colorectal adenocarcinoma treated with bevacizumab and modified FOLFIRI 3 chemotherapy. Secondary * 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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	bevacizumab
DRUG	capecitabine
DRUG	fluorouracil
DRUG	irinotecan hydrochloride
OTHER	diagnostic laboratory biomarker analysis

Timeline

• Start date: 2007-04-01
• First posted: 2007-10-16
• Last updated: 2011-06-27

Locations

1 site across 1 country: France