NCT01024504

Capecitabine Plus Oxaliplatin Plus Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer

A Multicenter Phase II Study of the Capecitabine, Oxaliplatin and Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Hellenic Oncology Research Group · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

This trial will evaluate the efficacy and safety of the capecitabine and oxaliplatine plus bevacizumab combination as first-line treatment in elderly patients with metastatic colorectal cancer.

Detailed description

Capecitabine, oxaliplatin and bevacizumab are well known active agents in the treatment of mCRC. The treatment of elderly patients with mCRC is an area of investigation. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Oxaliplatin	Oxaliplatin at the dose of 85 mg/m2 over a 4 hour intravenous infusion at day 1 every 2 weeks for a maximum of 12 consecutive cycles
DRUG	Capecitabine	Capecitabine at the dose of 1500 mg/m2 per os at days 1 to 7 every 2 weeks for a maximum of 12 consecutive cycles
DRUG	Bevacizumab	Bevacizumab at the dose of 5 mg/Kgr (intravenous infusion) at day 1, every 2 weeks for a maximum of 12 consecutive cycles

Timeline

• Start date: 2006-03-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2009-12-02
• Last updated: 2010-04-09

Locations

6 sites across 1 country: Greece