Eniluracil and Surgery in Treating Patients With Primary or Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring 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
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Oral eniluracil 20 mg twice daily
Placebo
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