NCT00628810

Combination Chemotherapy and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer

Chemotherapy With FOLFIRI Plus Bevacizumab (AvastinR) in Patients With Metastatic Colorectal Cancer Bearing Genotype UGT1A1*1/UGT1A1*1 or UGT1A1*1/UGT1A1*1/UGT1A1*28: Prospective, Phase II, Multicenter Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Federation Francophone de Cancerologie Digestive · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy together with bevacizumab and to see how well it works in treating patients with metastatic colorectal cancer.

Detailed description

OBJECTIVES: Primary * Evaluate the objective response (RECIST criteria) at 6 months associated with FOLFIRI and bevacizumab therapy. * Evaluate the tolerability (NCI CTC v. 2.0 criteria) of this treatment. Secondary * Evaluate progression-free survival and overall survival. * Determine the time to treatment failure. * Evaluate the quality of life (EuroQOL EQ5D questionnaire). * Explore the prognostic factors associated with the tolerability and efficacy of this treatment. OUTLINE: This is a multicenter study. Patients are stratified according to genotype (UCT1A1\*1/ UCT1A1\*1 vs UCT1A1\*1/ UCT1A1\*28). 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. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 4 courses, and then every 2 months after the completion of study therapy. After completion of study therapy, patients are followed every 2-3 months.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	bevacizumab
DRUG	fluorouracil
DRUG	irinotecan hydrochloride
DRUG	leucovorin calcium

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-01-01
• Completion: 2008-12-01
• First posted: 2008-03-05
• Last updated: 2020-11-09

Locations

32 sites across 1 country: France