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.