Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Recurrence

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Herbal and Botanical

Fluorouracil

Eniluracil

Enzyme Inhibitors

Cola

20 mg of eniluracil given twice daily for duration of the study. This subject may have surgery IF tumor is amenable to resection

20 mg placebo that will be given for the duration of the study. This subject may have surgery IF tumor is amenable to resection

Will be given to either subject pre-operative and metastatic disease

eniluracil

Only if the subject is amenable to surgical resections

conventional colon surgery

Martin J. Heslin, MD

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.

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.

Eniluracil and Surgery in Treating Patients With Primary or Metastatic Colorectal Cancer

Evaluation of Dihydropyrimidine Dehydrogenase (DPD) Activity in Surgically Resected Primary and Metastatic Colorectal Cancer After 48 hr Pretreatment With Eniluracil

1. Determine the enzymatic activity of DPD in PBMC's normal mucosa or normal liver and in primary and secondary colorectal cancers
2. Confirm the ability of eniluracil to inactivate DPD in tumors as well as PBMC's and normal tissue
3. Assess DPD recovery and uracil levels in PBMC's at 5-7,12-16,20-24,and 26-30 days postoperatively

To see if at standard clinical doses are capable of inhibiting DPD in Primary and metastatic colorectal cancer in vivo. Since one of the mechanisms of 5-FU(Fluorouracil) tumor resistance is overexpression of DPD,effective inactivation DPD in tumors by eniluracil in this study will be supportive of the use of eniluracil to overcome this type of 5-FU(Fluorouracil) resistance

To evaluate the recovery of DPD and uracil levels at 4 more times in the range of postoperative days 5-7,12-16,20-24,and 26-30.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Eniluracil and Surgery in Treating Patients With Primary or Metastatic Colorectal Cancer	NCT00004195	Colorectal Canc...	eniluracil conventional co...	19 Years - 80 Years	University of Alabama at Birmingham
Eniluracil and Surgery in Treating Patients With Primary or Metastatic Colorectal Cancer	NCT00004195	Colorectal Canc...	eniluracil conventional co...	19 Years - 80 Years	University of Alabama at Birmingham

Spots Global Cancer Trial Database for conventional colon surgery