Clinical trial · Interventional
Clinical Trial in Patients With Metastatic Colorectal Cancer
COFU: A Multi-Center Phase II Clinical Trial to Evaluate the Safety and Efficacy of Weekly Treatment With CoFactor and 5-Fluorouracil in Patients With Metastatic Colorectal Carcinoma
NCT00081627CI-TRIAL-00000996completedPhase 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)
The objectives of this trial are to determine if CoFactor in combination with 5-FU are effective in the treatment of metastatic colorectal cancer and to determine the side effects observed with the administration of CoFactor and 5-FU.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CoFactor and 5FU | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have surgically incurable colon or rectal adenocarcinoma * Karnofsky Performance Status of 60% or greater * Patients may have symptomatic neuropathy * Patients must have a life expectancy of at least 4 months * Patients must be alimenting, receiving at least 1500Kcal/day nutrition, by any route * Patients must have bidimensional measurable disease for response assessment * Patients may have received adjuvant chemotherapy with fluoropyrimidine therapy * Patients must have recovered from the toxicities of prior therapy, at least 4 weeks since prior adjuvant chemotherapy and major surgery * Serum creatinine less than 2.4mg%, serum bilirubin less than 3.0mg%, WBC greater than 3,200/mm2, AGC greater than 1,500/mm3, platelet count greater than 90,000/mm3 and SGOT (AST) and SGPT (ALT) less than 3 times the upper limit of normal * Male and non-pregnant, non-lactating female patients must be \>18 years old. Exclusion Criteria: * Concurrent infection * Failure of the patient or the patient's legal representative to sign the Informed consent * Inability to obtain Informed Consent because of psychiatric or complex medical problem * Patients with unstable oncologic emergency * Patients with unstable medical conditions such as angina, transient ischemic attacks, rising creatinine, accelerated hypertension, etc. * Cerebellar neurologic syndromes such as Parkinson's Disease, multiple sclerosis and amyotonia * Known intolerance to fluoropyrimidine therapy suggestive of dihydropyrimidine dehydrogenase deficiency.
References
Publications (0)
Data not yet available
No reference posted for this study.