Overview

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

Status:
Completed

Trial end date:
2001-05-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Alabama at Birmingham

Collaborators:

Glaxo Wellcome
National Cancer Institute (NCI)

Treatments:

Eniluracil

Criteria

Inclusion:

1. DISEASE CHARACTERISTICS: Histologically proven or suspicious primary or metastatic
colorectal carcinoma undergoing disease resection

2. PATIENT CHARACTERISTICS:A. Age: 19 and over

3. Performance status: Karnofsky 60-100%

4. Not pregnant or nursing Fertile patients must use effective contraception during and
for at least 1 month after study

5. PRIOR CONCURRENT THERAPY:

6. Subject has had at least 8 weeks since prior fluorouracil, capecitabine,
fluorouracil-uracil, floxuridine, or S-1 Endocrine therapy:

7. No prior or concurrent steroids Radiotherapy:

8. Surgery: No prior emergent surgery (e.g., perforation or obstruction) No prior
transplantation

9. At least 8 weeks since any prior drug metabolized by dihydropyrimidine dehydrogenase
enzyme At least 8 weeks since prior flucytosine

Exclusion:

1. Severe infection(White Blood Cell Count)WBC>2 times normal

2. Fever

3. Sepsis

4. Subject on immunosuppressives therapy

5. Subjects will serum Bilirubin/Creatinine>2 times normal levels

6. Pregnant /Lactating women

7. Subjects that have received eniluracil or 5-FU(Fluorouracil) within 28 days prior to
randomization

8. Subject that have comorbidity illnesses that will increase the likelihood of there
death in <5 years