Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004195
Status:
COMPLETED
Last Update Posted:
2015-06-15
First Post:
2000-01-21
Brief Title:
Eniluracil and Surgery in Treating Patients With Primary or Metastatic Colorectal Cancer
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Evaluation of Dihydropyrimidine Dehydrogenase DPD Activity in Surgically Resected Primary and Metastatic Colorectal Cancer After 48 hr Pretreatment With Eniluracil
Status:
COMPLETED
Status Verified Date:
2015-06
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 Eniluracil may increase the effectiveness of chemotherapy by blocking tumor enzymes that break down chemotherapy drugs
PURPOSE Randomized phase II trial to determine the effectiveness of eniluracil followed by surgery in treating patients who have primary or metastatic colorectal cancer
PURPOSE Randomized phase II trial to determine the effectiveness of eniluracil followed by surgery in treating patients who have primary or metastatic colorectal cancer
Detailed Description:
OBJECTIVES I Determine the enzymatic activity of dihydropyrimidine dehydrogenase DPD in peripheral blood mononuclear cells PBMC normal mucosa or normal liver in patients with primary or metastatic colorectal cancer II Evaluate the ability of eniluracil to inactivate DPD in the tumor PBMCs and normal tissue in this patient population III Assess DPD recovery and uracil levels in PBMCs following surgical resection in these patients
OUTLINE This is a randomized placebo controlled study Patients are stratified according to colorectal tumor primary vs metastatic Patients are randomized into one of two treatment arms Arm I Patients receive oral eniluracil twice daily on days -2 and -1 followed by surgical resection and tissue harvest on day 0 Arm II Patients receive an oral placebo as in arm I followed by surgical resection and tissue harvest on day 0 Patients are followed weekly for 1 month
PROJECTED ACCRUAL A total of 20 patients 10 per treatment arm will be accrued for this study
OUTLINE This is a randomized placebo controlled study Patients are stratified according to colorectal tumor primary vs metastatic Patients are randomized into one of two treatment arms Arm I Patients receive oral eniluracil twice daily on days -2 and -1 followed by surgical resection and tissue harvest on day 0 Arm II Patients receive an oral placebo as in arm I followed by surgical resection and tissue harvest on day 0 Patients are followed weekly for 1 month
PROJECTED ACCRUAL A total of 20 patients 10 per treatment arm will be accrued for this 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 |
|---|---|---|---|
| F980826006 | OTHER | University of Alabama at Birmingham IRB | None |