Fluorouracil With or Without Eniluracil in Treating Patients With Advanced Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00003873|
Recruitment Status : Completed
First Posted : July 16, 2004
Last Update Posted : January 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||950 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 1999|
|Primary Completion Date :||July 2007|
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
- Overall survival [ Time Frame: Up to 1 year ]
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): NCT00003873
|United States, Massachusetts|
|Eastern Cooperative Oncology Group|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||John Hines||Eastern Cooperative Oncology Group|