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Clinical Trial in Patients With Metastatic Colorectal Cancer

M

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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