Fluorouracil With or Without Eniluracil in Treating Patients With 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||Drug: fluorouracil Drug: eniluracil||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ]
|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|