NCT00203411

Bevacizumab Plus Capecitabine (Xeloda) in Patients With Untreated Metastatic Colorectal Cancer

A Phase II Trial to Evaluate the Efficacy and Safety of Bevacizumab in Combination With Capecitabine (Xeloda) in Frail Patients With Untreated Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Translational Oncology Research International · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of the bevacizumab and capecitabine combination in frail patients with untreated metastatic colorectal cancer.

Detailed description

The study will evaluate the tolerability, safety, and feasibility of combination bevacizumab and capecitabine in a small number of frail patients with metastatic colorectal cancer who have a compromised performance status. Preclinical studies suggest that the combination of chemotherapy and anti-angiogenic therapy offer an increased anti-tumor effect compared with either treatment alone.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine (Xeloda)	1000mg/m\^2 administered orally twice daily for two weeks followed by one week rest period
DRUG	Bevacizumab	7.5 mg/kg IV will be administered every 3 weeks

Timeline

• Start date: 2006-03-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2005-09-20
• Last updated: 2017-02-06
• Results posted: 2017-02-06

Locations

12 sites across 1 country: United States