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

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.