Fluorouracil With or Without Eniluracil in Treating Patients With Advanced Colorectal Cancer
Randomized phase III trial to compare the effectiveness of fluorouracil given by infusion with that of fluorouracil plus eniluracil given by mouth in treating patients who have metastatic, recurrent, or residual advanced colorectal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if fluorouracil is more effective with or without eniluracil for advanced colorectal cancer
Adenocarcinoma of the Colon
Adenocarcinoma of the Rectum
Recurrent Colon Cancer
Recurrent Rectal Cancer
Stage IV Colon Cancer
Stage IV Rectal Cancer
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase III Trial Comparing a 28 Day Schedule of Daily Oral 5-FU Plus Eniluracil to Protracted Intravenous Infusion in Previously Untreated Patients With Advanced Colorectal Cancer|
- Overall survival [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||April 1999|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive fluorouracil IV as a continuous infusion for 28 days.
Given IV or orally
Experimental: Arm II
Patients receive eniluracil/fluorouracil orally twice a day for 28 days.
Given IV or orally
Other Names:Drug: eniluracil
I. Compare the response rate, response duration, and survival of patients with advanced colorectal cancer treated with oral fluorouracil (5-FU) and eniluracil or with protracted infusion 5-FU.
II. Compare the toxicity of these treatment regimens in this patient population.
OUTLINE: This is a randomized study. Patients are stratified according to performance status (0 vs 1-2) and measurable disease (yes vs no). Patients are randomized to one of two treatment arms.
ARM I: Patients receive fluorouracil IV as a continuous infusion for 28 days.
ARM II: Patients receive eniluracil/fluorouracil orally twice a day for 28 days.
Treatment continues every 35 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at least every 10 weeks for 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003873
|United States, Massachusetts|
|Eastern Cooperative Oncology Group|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||John Hines||Eastern Cooperative Oncology Group|