drugset / Trial / NCT00423696

Bevacizumab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery

NCT00423696 ↗

Phase 2 Completed 145 enrolled UNICANCER
RandomizedParallel-groupOpen-labelTreatment

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. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. 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. Giving bevacizumab together with combination chemotherapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given together with bevacizumab in treating patients with colorectal cancer. PURPOSE: This randomized phase II trial is studying bevacizumab to compare how well it works when given together with two different combination chemotherapy regimens as first-line therapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery.

Timeline

Start
2006-03-23
Primary completion
2008-07-28
Completion
2011-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody — Intravenous
Subject Capecitabine Small molecule — Oral
Subject Irinotecan Small molecule — Intravenous
Subject Leucovorin Small molecule — Intravenous
Subject fluorouracil Small molecule — Intravenous

Indications