Phase II/III Trial of CPT-11/5-FU/l-LV Versus CPT-11/TS-1 as Second Line Chemotherapy of Unresectable Colorectal Cancer
NCT ID: NCT00284258
Last Updated: 2012-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
426 participants
INTERVENTIONAL
2006-01-31
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
CPT-11 and TS-1
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.
2
CPT-11, 5-FU and l-LV
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Other malignancies in the past 5 years
* Serious illness or medical condition
20 Years
75 Years
ALL
No
Sponsors
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Daiichi Sankyo Co., Ltd.
INDUSTRY
Taiho Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Kenichi Sugihara, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Tokyo Medical and Dental University Hospital
Locations
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Saku Central Hospital
Saku, Nagano, Japan
Countries
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References
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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.
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.
Other Identifiers
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01023010 / TOP-003
Identifier Type: -
Identifier Source: org_study_id