Status:
COMPLETED
Phase II/III Trial of CPT-11/5-FU/l-LV Versus CPT-11/TS-1 as Second Line Chemotherapy of Unresectable Colorectal Cancer
Lead Sponsor:
Taiho Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Daiichi Sankyo Co., Ltd.
Conditions:
Colorectal Cancer
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
PHASE3
Brief Summary
This study is designed as Phase II/III. Phase II is aimed to evaluate safety and efficacy of IRIS, and feasibility of FOLFIRI. Phase III is aimed to verify inferiority of the progression free survival...
Eligibility Criteria
Inclusion
- Histologically confirmed colorectal cancer
- Locally advanced and/or metastatic colorectal cancer
- Have prior chemotherapy as first line treatment
- No prior irinotecan administration
- Able to take oral medication
- Age 20 to 75
- Performance status 0 or 1 (ECOG)
- WBC 3,000-12,000 / mm\^3
- Platelet ≥100,000 / mm\^3
- AST and ALT ≤ 100 IU/L
- Creatinine ≤ 1.2 mg/dL
- Bilirubin ≤ 1.5 mg/dL
Exclusion
- Prior radio therapy for colorectal cancer
- Other malignancies in the past 5 years
- Serious illness or medical condition
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
426 Patients enrolled
Trial Details
Trial ID
NCT00284258
Start Date
January 1 2006
End Date
August 1 2010
Last Update
November 2 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Saku Central Hospital
Saku, Nagano, Japan, 384-0301