Phase II/III Trial of CPT-11/5-FU/l-LV Versus CPT-11/TS-1 as Second Line Chemotherapy of Unresectable Colorectal Cancer

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

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
Colorectal Cancer	Drug: CPT-11 and TS-1; Drug: CPT-11, 5-FU and l-LV	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: January 2006
• Actual Primary Completion Date: July 2010
• Actual Study Completion Date: August 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 [ Time Frame: every course for first three courses, then every other course ]

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Japan

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

More Information

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Taiho Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT00284258
• Other Study ID Numbers: 01023010 / TOP-003
• First Posted: January 31, 2006
• Last Update Posted: November 2, 2012
• Last Verified: November 2012

Keywords provided by Taiho Pharmaceutical Co., Ltd.:

Colorectal Cancer

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Irinotecan; Topoisomerase I Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents