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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00284258
• Other study ID #: 01023010 / TOP-003
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 30, 2006
• Last updated: November 1, 2012
• Start date: January 2006
• Est. completion date: August 2010

Study information

• Verified date: November 2012
• Source: Taiho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Japan	Saku Central Hospital	Saku City	Nagano

Sponsors (2)

Lead Sponsor	Collaborator
Taiho Pharmaceutical Co., Ltd.	Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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 f — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		every course for first three courses, then every other course	Yes
Secondary	Over all survival, Response rate, Adverse event, Medical economy		adverse events will be collected during treatment	Yes