Clinical Trial in Patients With Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mast Therapeutics, Inc.
• Collaborator: University of California, San Diego

Criteria

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.