NCT00335595

Study of Bevacizumab Alone or Combined With Capecitabine and Oxaliplatin as Support Therapy in Metastatic Colorectal Cancer Patients

Randomized, Multicenter, Phase III Study, to Evaluate the Efficacy and Safety of Bevacizumab Alone or Combined With Capecitabine and Oxaliplatin as Support Therapy After Initial Chemotherapy Treatment With Capecitabine, Oxaliplatin and Bevacizumab in Metastatic Colorectal Cancer Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 480 (actual)
• Sponsor: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the free time to disease progression of combination therapy with capecitabine, oxaliplatin and bevacizumab until disease progression versus capecitabine, oxaliplatin and bevacizumab for 6 cycles followed by bevacizumab until disease progression or a premature drop out of the study.

Detailed description

The purpose of this study is to compare the free time to disease progression of combination therapy with capecitabine, oxaliplatin and bevacizumab until disease progression versus capecitabine, oxaliplatin and bevacizumab for 6 cycles followed by bevacizumab until disease progression or a premature drop out of the study.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	XELOXA	XELOXA Bevacizumab: 7,5 mg/kg, day 1 Oxaliplatino: 130 mg/m2 ; day 1 Capecitabine: 1000 mg/m2 bid, oral, day 1-14 One cycle every 3 weeks
DRUG	XELOXA-A	XELOXA-A Bevacizumab: 7,5 mg/kg, day 1 Oxaliplatino: 130 mg/m2 ; day 1 Capecitabine: 1000 mg/m2 bid, oral, day 1-14 during 6 cycles followed by Bevacizumab until disease progression or premature drop out of study. One cycle every 3 weeks

Timeline

• Start date: 2006-07-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2006-06-12
• Last updated: 2013-02-20

Locations

1 site across 1 country: Spain