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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00284258
Recruitment Status : Completed
First Posted : January 31, 2006
Last Update Posted : November 2, 2012
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 426 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2006
Actual Primary Completion Date : July 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Progression free survival [ Time Frame: every course for first three courses, then every other course ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00284258

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Saku Central Hospital
Saku City, Nagano, Japan, 384-0301
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
Daiichi Sankyo Co., Ltd.
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Principal Investigator: Kenichi Sugihara, MD, PhD Tokyo Medical and Dental University Hospital
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Taiho Pharmaceutical Co., Ltd. Identifier: NCT00284258    
Other Study ID Numbers: 01023010 / TOP-003
First Posted: January 31, 2006    Key Record Dates
Last Update Posted: November 2, 2012
Last Verified: November 2012
Keywords provided by Taiho Pharmaceutical Co., Ltd.:
Colorectal Cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents