Clinical trial · Interventional
Eniluracil and Surgery in Treating Patients With Primary or Metastatic Colorectal Cancer
Evaluation of Dihydropyrimidine Dehydrogenase (DPD) Activity in Surgically Resected Primary and Metastatic Colorectal Cancer After 48 hr Pretreatment With Eniluracil
NCT00004195CI-TRIAL-00018267completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional colon surgery | Procedure | — | UNRESOLVED |
| eniluracil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Oral eniluracil 20 mg twice daily
- description
- 20 mg of eniluracil given twice daily for duration of the study. This subject may have surgery IF tumor is amenable to resection
- interventionNames
- Drug: eniluracil
- Procedure: conventional colon surgery
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 20 mg placebo that will be given for the duration of the study. This subject may have surgery IF tumor is amenable to resection
- interventionNames
- Drug: eniluracil
- Procedure: conventional colon surgery
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.