NCT00003873

Fluorouracil With or Without Eniluracil in Treating Patients With Advanced Colorectal Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 950 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

OBJECTIVES: 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.

Conditions

• Adenocarcinoma of the Colon
• Adenocarcinoma of the Rectum
• Recurrent Colon Cancer
• Recurrent Rectal Cancer
• Stage IV Colon Cancer
• Stage IV Rectal Cancer

Interventions

Type	Name	Description
DRUG	fluorouracil	Given IV or orally
DRUG	eniluracil	Given orally

Timeline

• Start date: 1999-04-01
• Primary completion: 2007-07-01
• First posted: 2004-07-16
• Last updated: 2013-01-24

Locations

1 site across 1 country: United States