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Completed

NCT Number: NCT00284258

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Saku Central Hospital

Saku, Nagano, 384-0301, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPT-11 and TS-1

Drug

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

Drug

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 outcomes

  1. Progression free survival

    Time frame: every course for first three courses, then every other course

Secondary outcomes

  1. Over all survival, Response rate, Adverse event, Medical economy

    Time frame: adverse events will be collected during treatment

Sponsors and collaborators

Lead sponsor

Taiho Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Daiichi Sankyo Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jan 31, 2006
Registry last updated
Nov 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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