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| Sponsors and Collaborators: |
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004195 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: ethynyluracil Procedure: conventional surgery |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | Evaluation of Dihydropyrimidine Dehydrogenase (DPD) Activity in Surgically Resected Primary and Metastatic Colorectal Cancer After 48 hr Pretreatment With Eniluracil |
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven or suspicious primary or metastatic colorectal carcinoma undergoing disease resection
PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Karnofsky 60-100% Life expectancy: Less than 50% survival at 5 years from any cause allowed Hematopoietic: WBC no greater than 2 times normal Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) Renal: Creatinine no greater than 2 times ULN Other: No severe infection (e.g., fever or sepsis) Not pregnant or nursing Fertile patients must use effective contraception during and for at least 1 month after study
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 8 weeks since prior fluorouracil, capecitabine, fluorouracil-uracil, floxuridine, or S-1 Endocrine therapy: No prior or concurrent steroids Radiotherapy: Not specified Surgery: See Disease Characteristics No prior emergent surgery (e.g., perforation or obstruction) No prior transplantation Other: At least 8 weeks since any prior drug metabolized by dihydropyrimidine dehydrogenase enzyme At least 8 weeks since prior flucytosine
Contacts and Locations More Information
| Study ID Numbers: | CDR0000067438, UAB-9835, UAB-F980826006, NCI-G99-1653 |
| Study First Received: | January 21, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004195 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I colon cancer stage II colon cancer stage III colon cancer stage IV colon cancer stage I rectal cancer |
stage II rectal cancer stage III rectal cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer |
|
Metabolic Diseases Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases 5-ethynyluracil Rectal Neoplasm Dihydropyrimidine Dehydrogenase Deficiency Intestinal Diseases Rectal Diseases Purine-Pyrimidine Metabolism, Inborn Errors |
Recurrence Intestinal Neoplasms Metabolism, Inborn Errors Rectal Cancer Digestive System Diseases Genetic Diseases, Inborn Dihydrouracil Dehydrogenase (NADP) Gastrointestinal Neoplasms Metabolic Disorder Colorectal Neoplasms |
|
Metabolic Diseases Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Colonic Diseases 5-ethynyluracil Dihydropyrimidine Dehydrogenase Deficiency Enzyme Inhibitors Intestinal Diseases Rectal Diseases |
Pharmacologic Actions Intestinal Neoplasms Purine-Pyrimidine Metabolism, Inborn Errors Metabolism, Inborn Errors Neoplasms Neoplasms by Site Digestive System Diseases Genetic Diseases, Inborn Gastrointestinal Neoplasms Colorectal Neoplasms |
