NCT00345761

Clinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal Cancer

Phase I/II Study of R340 (Capecitabine), L-OHP (Oxaliplatin) and R435 (Bevacizumab) in Advanced and/or Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Chugai Pharmaceutical · Industry
• Sex: All
• Age: 20 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy, safety and pharmacokinetics of capecitabine (2000 mg/m2/day by mouth \[po\], day 1 pm-day 15 am every 3 weeks \[q3w\]), oxaliplatin (130 mg/m2 intravenously \[iv\], day 1 q3w) and bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.

Detailed description

This study will evaluate the efficacy, safety and pharmacokinetics of Capecitabine (2000 mg/m2/day po, day 1 pm-day 15 am q3w), Oxaliplatin (130 mg/m2 iv, day 1 q3w) and Bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumab	7.5 mg/kg(i.v.) on Day 1 of 1 cycle(3 weeks)
DRUG	Oxaliplatin	130 mg/m2(i.v.) on Day 1 of 1 cycle(3 weeks)
DRUG	Capecitabine	2000 mg/m2/day(p.o.) for 14 days in 1 cycle(3 weeks)

Timeline

• Start date: 2006-02-01
• Primary completion: 2008-10-01
• Completion: 2010-07-01
• First posted: 2006-06-28
• Last updated: 2010-08-16

Locations

4 sites across 1 country: Japan