NCT00569790

Phase II Trial of Combination Therapy With Irinotecan, S-1, and Bevacizumab (IRIS/Bev) in Patients With Unresectable or Recurrent Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Taiho Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether irinotecan, S-1, and bevacizumab are safe in the treatment of unresectable or recurrent colorectal cancer

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	S-1, Irinotecan, Bevacizumab	S-1 is administered orally on days 1 to 14 of a 28-day cycle. Patients are assigned on the basis of body surface area (BSA) to receive one of the following oral doses twice daily: 40 mg (BSA \<1.25m2), 50 mg (BSA \>1.25 to \<1.50 m2), or 60 mg (BSA \>1.50 m2). Irinotecan 100 mg/m2 is administered by intravenous infusion on days 1 and 15. Bevacizumab 5 mg/kg (body weight)is administered by intravenous infusion on days 1 and 15.

Timeline

• Start date: 2007-10-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2007-12-07
• Last updated: 2012-11-02

Locations

1 site across 1 country: Japan