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

Study start date: April 1, 2004

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.