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

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III, Phase II

Treatment

Closed

20 to 75

Pharmaceutical / Industry

01023010 / TOP-003
NCT00284258

Trial Description

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.

Eligibility Criteria

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 Contact Information

Trial Lead Organizations/Sponsors

Taiho Pharmaceutical Company, Limited

Daiichi Sankyo, Incorporated

Kenichi Sugihara, MD, PhD

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00284258
Information obtained from ClinicalTrials.gov on August 08, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.