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

PHASE2CompletedINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

March 31, 2010

Study Completion Date

March 31, 2010

Conditions
Colorectal Cancer
Interventions
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."

Trial Locations (1)

060-8038

Hokkaido University Hospital (Hokkaido Gastrointestinal Cancer Study Group), Sapporo

All Listed Sponsors
lead

Taiho Pharmaceutical Co., Ltd.

INDUSTRY

NCT00569790 - Phase II Trial of Combination Therapy With Irinotecan, S-1, and Bevacizumab (IRIS/Bev) in Patients With Unresectable or Recurrent Colorectal Cancer | Biotech Hunter | Biotech Hunter