Study Evaluating Isovorin in Colon Cancer

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00195585
First received: September 12, 2005
Last updated: August 12, 2009
Last verified: August 2009
  Purpose

The purpose of the study is to verify superiority of 1-LV/5FU therapy to UFT Therapy of relapse-free survival time in patients with Dukes C and Cure A colon cancer. Secondary endpoints include disease-free survival time, survival time, and safety.


Condition Intervention Phase
Colon Cancer
Drug: Isovorin
Drug: UFT
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post-Approved Phase III Study of 1-LV/5FU Therapy

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Relapse-free survival time

Secondary Outcome Measures:
  • Disease-free survival time, survival time, safety

Estimated Enrollment: 650
Study Start Date: October 2002
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dukes C, Cure A colon cancer diagnosed histologically or cytologically
  • Normal organ function of bone marrow, heart, liver and kidney
  • Age 20-75

Other inclusion applies

Exclusion Criteria:

  • Serious bone marrow suppression, infection, heart disease or complication
  • Familial adenomatous polyposis or hereditary nonpolyposis
  • Pregnant or breastfeeding women

Other exclusion applies

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195585

Locations
Japan
Tokyo, Japan, 104-0031
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00195585     History of Changes
Other Study ID Numbers: ISO/5FU-11
Study First Received: September 12, 2005
Last Updated: August 12, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Colon Cancer

ClinicalTrials.gov processed this record on October 20, 2014