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

NCT00004195 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2015-06-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

eniluracil

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

PROCEDURE

conventional colon surgery

Only if the subject is amenable to surgical resections

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Glaxo Wellcome

    collaborator INDUSTRY

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Martin J. Heslin, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-09-30
Primary Completion
1999-10-31
Completion
2001-05-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004195 on ClinicalTrials.gov