Phase II/III Trial of CPT-11/5-FU/l-LV Versus CPT-11/TS-1 as Second Line Chemotherapy of Unresectable Colorectal Cancer

Taiho Pharma

Status and phase: Completed; Phase 3; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: CPT-11, 5-FU and l-LV; Drug: CPT-11 and TS-1

Study type: Interventional

Funder types: Industry

Identifiers

NCT00284258

01023010 / TOP-003

Details and patient eligibility

About

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.

Enrollment: 426 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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426 participants in 2 patient groups

1

Experimental group

Description:

CPT-11 and TS-1

Treatment:

Drug: CPT-11 and TS-1

2

Active Comparator group

Description:

CPT-11, 5-FU and l-LV

Treatment:

Drug: CPT-11, 5-FU and l-LV