Status:
COMPLETED
Eniluracil and Surgery in Treating Patients With Primary or Metastatic Colorectal Cancer
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Cancer Institute (NCI)
Glaxo Wellcome
Conditions:
Colorectal Cancer
Eligibility:
All Genders
19-80 years
Phase:
PHASE2
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...
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 metast...
Eligibility Criteria
Inclusion
- Inclusion:
- DISEASE CHARACTERISTICS: Histologically proven or suspicious primary or metastatic colorectal carcinoma undergoing disease resection
- PATIENT CHARACTERISTICS:A. Age: 19 and over
- Performance status: Karnofsky 60-100%
- Not pregnant or nursing Fertile patients must use effective contraception during and for at least 1 month after study
- PRIOR CONCURRENT THERAPY:
- Subject has had at least 8 weeks since prior fluorouracil, capecitabine, fluorouracil-uracil, floxuridine, or S-1 Endocrine therapy:
- No prior or concurrent steroids Radiotherapy:
- Surgery: No prior emergent surgery (e.g., perforation or obstruction) No prior transplantation
- At least 8 weeks since any prior drug metabolized by dihydropyrimidine dehydrogenase enzyme At least 8 weeks since prior flucytosine
- Exclusion:
- Severe infection(White Blood Cell Count)WBC\>2 times normal
- Fever
- Sepsis
- Subject on immunosuppressives therapy
- Subjects will serum Bilirubin/Creatinine\>2 times normal levels
- Pregnant /Lactating women
- Subjects that have received eniluracil or 5-FU(Fluorouracil) within 28 days prior to randomization
- Subject that have comorbidity illnesses that will increase the likelihood of there death in \<5 years
Exclusion
Key Trial Info
Start Date :
September 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2001
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00004195
Start Date
September 1 1998
End Date
May 1 2001
Last Update
June 15 2015
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