Back to resultsPhase II/III Trial of CPT-11/5-FU/l-LV Versus CPT-11/TS-1 as Second Line Chemotherapy of Unresectable Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
CPT-11 and TS-1
CPT-11, 5-FU and l-LV
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal Cancer
Eligibility Criteria
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
Sites / Locations
- Saku Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
CPT-11 and TS-1
CPT-11, 5-FU and l-LV
Outcomes
Primary Outcome Measures
Progression free survival
Secondary Outcome Measures
Over all survival, Response rate, Adverse event, Medical economy
Full Information
NCT ID
NCT00284258
First Posted
January 30, 2006
Last Updated
November 1, 2012
Sponsor
Taiho Pharmaceutical Co., Ltd.
Collaborators
Daiichi Sankyo Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00284258
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Pharmaceutical Co., Ltd.
Collaborators
Daiichi Sankyo Co., Ltd.
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
426 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
CPT-11 and TS-1
Arm Title
2
Arm Type
Active Comparator
Arm Description
CPT-11, 5-FU and l-LV
Intervention Type
Drug
Intervention Name(s)
CPT-11 and TS-1
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
CPT-11, 5-FU and l-LV
Intervention Description
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 Measure Information:
Title
Progression free survival
Time Frame
every course for first three courses, then every other course
Secondary Outcome Measure Information:
Title
Over all survival, Response rate, Adverse event, Medical economy
Time Frame
adverse events will be collected during treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenichi Sugihara, MD, PhD
Organizational Affiliation
Tokyo Medical and Dental University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saku Central Hospital
City
Saku City
State/Province
Nagano
ZIP/Postal Code
384-0301
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
20708966
Citation
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. doi: 10.1016/S1470-2045(10)70181-9. Epub 2010 Aug 12.
Results Reference
result
PubMed Identifier
25106731
Citation
Yasui H, Muro K, Shimada Y, Tsuji A, Sameshima S, Baba H, Satoh T, Denda T, Ina K, Nishina T, Yamaguchi K, Esaki T, Tokunaga S, Kuwano H, Boku N, Komatsu Y, Watanabe M, Hyodo I, Morita S, Sugihara K. A phase 3 non-inferiority study of 5-FU/l-leucovorin/irinotecan (FOLFIRI) versus irinotecan/S-1 (IRIS) as second-line chemotherapy for metastatic colorectal cancer: updated results of the FIRIS study. J Cancer Res Clin Oncol. 2015 Jan;141(1):153-60. doi: 10.1007/s00432-014-1783-3. Epub 2014 Aug 9.
Results Reference
derived
Learn more about this trial
Phase II/III Trial of CPT-11/5-FU/l-LV Versus CPT-11/TS-1 as Second Line Chemotherapy of Unresectable Colorectal Cancer
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