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

January 30, 2006
November 1, 2012
January 2006
July 2010   (final data collection date for primary outcome measure)
Progression free survival [ Time Frame: every course for first three courses, then every other course ] [ Designated as safety issue: Yes ]
Progression free survival
Complete list of historical versions of study NCT00284258 on ClinicalTrials.gov Archive Site
Over all survival, Response rate, Adverse event, Medical economy [ Time Frame: adverse events will be collected during treatment ] [ Designated as safety issue: Yes ]
Over all survival, Response rate, Adverse event, Medical economy
Not Provided
Not Provided
 
Phase II/III Trial of CPT-11/5-FU/l-LV Versus CPT-11/TS-1 as Second Line Chemotherapy of Unresectable Colorectal Cancer
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • 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.
  • 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
Muro K, Boku N, Shimada Y, Tsuji A, Sameshima S, Baba H, Satoh T, Denda T, Ina K, Nishina T, Yamaguchi K, Takiuchi H, Esaki T, Tokunaga S, Kuwano H, Komatsu Y, Watanabe M, Hyodo I, Morita S, Sugihara K. Irinotecan plus S-1 (IRIS) versus fluorouracil and folinic acid plus irinotecan (FOLFIRI) as second-line chemotherapy for metastatic colorectal cancer: a randomised phase 2/3 non-inferiority study (FIRIS study). Lancet Oncol. 2010 Sep;11(9):853-60. Epub 2010 Aug 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
426
August 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00284258
01023010 / TOP-003
Not Provided
Taiho Pharmaceutical Co., Ltd.
Taiho Pharmaceutical Co., Ltd.
Daiichi Sankyo Co., Ltd.
Principal Investigator: Kenichi Sugihara, MD, PhD Tokyo Medical and Dental University Hospital
Taiho Pharmaceutical Co., Ltd.
November 2012

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