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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 (NCT00003873)

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
  • Drug: fluorouracil
    Given IV or orally
    • 5-fluorouracil
    • 5-Fluracil
    • 5-FU
  • Drug: eniluracil
    Given orally
    • 776C85
    • ADH300004
    • ethynyluracil
    • GW776
    • GW776C85
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers

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.

1 locations

United States (1)
  • Eastern Cooperative Oncology Group
    Not specified
    Boston, Massachusetts, United States, 02215
31 March, 1999
22 January, 2013
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