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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

This study has been completed.
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00284258
First received: January 30, 2006
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
 Drug: CPT-11 and TS-1
Drug: CPT-11, 5-FU and l-LV
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II/III Trial of CPT-11/5-FU/l-LV (FOLFIRI) Versus CPT-11/TS-1 (IRIS) as Second Line Chemotherapy of Unresectable Colorectal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Taiho Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: every course for first three courses, then every other course ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Over all survival, Response rate, Adverse event, Medical economy [ Time Frame: adverse events will be collected during treatment ] [ Designated as safety issue: Yes ]

Enrollment: 426
Study Start Date: January 2006
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
CPT-11 and TS-1
 Drug: CPT-11 and TS-1
TS-1 was administered orally at 40-60 mg twice daily for 14 days with a rest period of 14 days as one course. CPT-11 was administered intravenously 125 mg per square meter at day1 and day14 in 4 weeks as one course.
Active Comparator: 2
CPT-11, 5-FU and l-LV
 Drug: CPT-11, 5-FU and l-LV
Patients were administered FOLFIRI every 2 weeks in one course. FOLFIRI:CPT-11 150 mg per square meter on day1 with l-LV 200 mg per square meter administered as a 2-hour infusion before 5-FU 400 mg per square meter administered as an intravenous bolus injection, and 5-FU 2400 mg per square meter as a 46-hour infusion immediately after 5-FU bolus injection on day1 in 2 weeks.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00284258

Locations
Japan
Saku Central Hospital
Saku City, Nagano, Japan, 384-0301
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
Daiichi Sankyo Co., Ltd.
Investigators
Principal Investigator: Kenichi Sugihara, MD, PhD Tokyo Medical and Dental University Hospital
  More Information

Publications:

Responsible Party: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00284258     History of Changes
Other Study ID Numbers: 01023010 / TOP-003
Study First Received: January 30, 2006
Last Updated: November 1, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Taiho Pharmaceutical Co., Ltd.:
Colorectal Cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Irinotecan
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013