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

Sponsor
Taiho Pharmaceutical Co., Ltd.
Study ID
NCT00569335
Phase
PHASE2
Status
Completed

Conditions

  • Colorectal, Cancer

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • S-1, Irinotecan, Bevacizumab — DRUG
    S-1 is administered orally on days 1 to 14 of a 21-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 150 mg/m2 is administered by intravenous infusion on day 1. Bevacizumab 7.5 mg/kg (body weight) is administered by intravenous infusion on day 1.

Study Details

Phase II trial of combination therapy with S-1, irinotecan, and bevacizumab (SIRB) in patients with unresectable or recurrent colorectal cancer

Key Dates

Start date
Oct 31, 2007
Status verified
Nov 2012
Primary completion
Mar 31, 2010
Completion
Mar 31, 2010

Study Design

Enrollment
52 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    S-1, Irinotecan, Bevacizumab

Primary Outcome Measure

Safety [ Time Frame: any time ]