drugset / Trial / NCT00483834

A Phase II Study of Bevacizumab, Irinotecan and Capecitabine in Patients With Previously Untreated Metastatic Colorectal Cancer

NCT00483834 ↗

NaSingle-groupOpen-labelTreatment

Summary

Bevacizumab has recently been shown to improve survival when combined with chemotherapy in patients with previously untreated metastatic colorectal cancer. Bevacizumab is usually given together with infusional 5-FU, which requires a central line. A central line is inconvenient for patients, and may increase risk of infection, and thrombosis. Furthermore, a central line increases resource demands for interventional radiology, chemo daycare. Capecitabine is administered orally, and converted to 5-FU intracellularly. Chronic administration of capecitabine mimics infusional 5-FU. This study is designed to evaluate whether the combination of irinotecan, capecitabine and bevacizumab is effective as a first-line therapy for patients with metastatic colorectal cancer.

Timeline

Start
2006-12
Primary completion
2011-07
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 7.5 mg/kg Intravenous
Subject Capecitabine Small molecule 750 mg/m2 Oral
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Irinotecan Small molecule 200 mg/m2 Intravenous

Indications