Clinical Trial in Patients With Metastatic Colorectal Cancer

Mast Therapeutics

Status and phase

Completed

Phase 2

Conditions

Colon Cancer

Rectal Cancer

Treatments

Drug: CoFactor and 5FU

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00081627

02-CoFactor

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.