Phase II/III Trial of CPT-11/5-FU/l-LV Versus CPT-11/TS-1 as Second Line Chemotherapy of Unresectable Colorectal Cancer
Phase 2
Completed
- Conditions
- Colorectal Cancer
- Interventions
- Drug: CPT-11, 5-FU and l-LV
- Registration Number
- NCT00284258
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- 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 of IRIS in comparison with FOLFIRI.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 426
Inclusion Criteria
- 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 Criteria
- Prior radio therapy for colorectal cancer
- Other malignancies in the past 5 years
- Serious illness or medical condition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 CPT-11 and TS-1 CPT-11 and TS-1 2 CPT-11, 5-FU and l-LV CPT-11, 5-FU and l-LV
- Primary Outcome Measures
Name Time Method Progression free survival every course for first three courses, then every other course
- Secondary Outcome Measures
Name Time Method Over all survival, Response rate, Adverse event, Medical economy adverse events will be collected during treatment
Trial Locations
- Locations (1)
Saku Central Hospital
🇯🇵Saku City, Nagano, Japan