Eniluracil's Impact on DPD Activity in Primary and Metastatic Colorectal Cancer
eniluracil
+ conventional colon surgery
+ eniluracil
Colonic Diseases+10
+ Digestive System Diseases
+ Digestive System Neoplasms
Treatment Study
Summary
Study start date: September 1, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.28 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 19 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives