Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003873
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
1999-11-01
Brief Title:
Fluorouracil With or Without Eniluracil in Treating Patients With Advanced Colorectal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 eniluracilfluorouracil 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
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 eniluracilfluorouracil 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000067038 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA021115 |
| E-5296 | None | None | None |
| U10CA021115 | NIH | None | None |