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Study Evaluating Isovorin in Colon Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00195585
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : August 13, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Colon Cancer Drug: Isovorin Drug: UFT Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-Approved Phase III Study of 1-LV/5FU Therapy
Study Start Date : October 2002
Primary Completion Date : February 2006
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Relapse-free survival time

Secondary Outcome Measures :
  1. Disease-free survival time, survival time, safety


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00195585     History of Changes
Other Study ID Numbers: ISO/5FU-11
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: August 13, 2009
Last Verified: August 2009

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

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Levoleucovorin
Antidotes
Protective Agents
Physiological Effects of Drugs