Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00284258
Recruitment Status : Completed
First Posted : January 31, 2006
Last Update Posted : November 2, 2012
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE January 30, 2006
First Posted Date  ICMJE January 31, 2006
Last Update Posted Date November 2, 2012
Study Start Date  ICMJE January 2006
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2008)
Progression free survival [ Time Frame: every course for first three courses, then every other course ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2006)
Progression free survival
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2008)
Over all survival, Response rate, Adverse event, Medical economy [ Time Frame: adverse events will be collected during treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2006)
Over all survival, Response rate, Adverse event, Medical economy
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II/III Trial of CPT-11/5-FU/l-LV Versus CPT-11/TS-1 as Second Line Chemotherapy of Unresectable Colorectal Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: 1
    CPT-11 and TS-1
    Intervention: Drug: CPT-11 and TS-1
  • Active Comparator: 2
    CPT-11, 5-FU and l-LV
    Intervention: Drug: CPT-11, 5-FU and l-LV
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2012)
426
Original Enrollment  ICMJE
 (submitted: January 30, 2006)
400
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00284258
Other Study ID Numbers  ICMJE 01023010 / TOP-003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Taiho Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Taiho Pharmaceutical Co., Ltd.
Collaborators  ICMJE Daiichi Sankyo Co., Ltd.
Investigators  ICMJE
Principal Investigator: Kenichi Sugihara, MD, PhD Tokyo Medical and Dental University Hospital
PRS Account Taiho Pharmaceutical Co., Ltd.
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP