Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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.
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd. Identifier:
First received: January 30, 2006
Last updated: November 1, 2012
Last verified: November 2012
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
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:

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 ]

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

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.


Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00284258

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Taiho Pharmaceutical Co., Ltd. Identifier: NCT00284258     History of Changes
Other Study ID Numbers: 01023010 / TOP-003
Study First Received: January 30, 2006
Last Updated: November 1, 2012

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
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 23, 2017