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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

Sponsor
Taiho Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT00284258
Collaborator
Daiichi Sankyo Co., Ltd. (Industry)
426
Enrollment
1
Location
2
Arms
55
Duration (Months)
7.8
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: CPT-11 and TS-1
  • Drug: CPT-11, 5-FU and l-LV
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
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 :
Jan 1, 2006
Actual Primary Completion Date :
Jul 1, 2010
Actual Study Completion Date :
Aug 1, 2010

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Progression free survival [every course for first three courses, then every other course]

Secondary Outcome Measures

  1. Over all survival, Response rate, Adverse event, Medical economy [adverse events will be collected during treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00284258
Other Study ID Numbers:
  • 01023010 / TOP-003
First Posted:
Jan 31, 2006
Last Update Posted:
Nov 2, 2012
Last Verified:
Nov 1, 2012
Keywords provided by Taiho Pharmaceutical Co., Ltd.
Colorectal Cancer
Additional relevant MeSH terms:
Colorectal Neoplasms
Irinotecan

Study Results

No Results Posted as of Nov 2, 2012