Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005050
Status:
COMPLETED
Last Update Posted:
2011-03-28
First Post:
2000-04-06
Brief Title:
Eniluracil Fluorouracil and Oxaliplatin in Treating Patients With Advanced Colorectal Cancer
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
A Phase III Study of Eniluracil Plus Oral 5-Fluorouracil Combined With Oxaliplatin FOX-E in Patients With Previously-Treated Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2011-03
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of combining eniluracil fluorouracil and oxaliplatin in treating patients who have advanced colorectal cancer that has been treated previously
PURPOSE Phase III trial to study the effectiveness of combining eniluracil fluorouracil and oxaliplatin in treating patients who have advanced colorectal cancer that has been treated previously
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose dose limiting toxicity and recommended phase II dose of eniluracil fluorouracil and oxaliplatin in patients with previously treated advanced colorectal cancer II Determine the response rate in patients treated with this regimen
OUTLINE This is a dose escalation study of eniluracil and fluorouracil Patients receive oral eniluracil and oral fluorouracil twice daily on days 1-21 Patients receive oxaliplatin IV over 2 hours on days 1 and 15 Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity Patients with complete response are treated with 2 more courses and then therapy is stopped Cohorts of 3-6 patients receive escalating doses of eniluracil and fluorouracil until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity The recommended phase II dose RPTD is defined as 1 dose level below the MTD Patients are followed at 1 month
PROJECTED ACCRUAL A total of 3-30 patients will be accrued for phase I of the study and an additional 27-40 patients will be accrued for phase II of the study
OUTLINE This is a dose escalation study of eniluracil and fluorouracil Patients receive oral eniluracil and oral fluorouracil twice daily on days 1-21 Patients receive oxaliplatin IV over 2 hours on days 1 and 15 Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity Patients with complete response are treated with 2 more courses and then therapy is stopped Cohorts of 3-6 patients receive escalating doses of eniluracil and fluorouracil until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity The recommended phase II dose RPTD is defined as 1 dose level below the MTD Patients are followed at 1 month
PROJECTED ACCRUAL A total of 3-30 patients will be accrued for phase I of the study and an additional 27-40 patients will be accrued for phase II of the study
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 |
|---|---|---|---|
| NCI-G00-1718 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016087 |
| P30CA016087 | NIH | None | None |
| NYU-9907 | None | None | None |