Status:
COMPLETED
Clinical Trial in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Mast Therapeutics, Inc.
Collaborating Sponsors:
University of California, San Diego
Conditions:
Colon Cancer
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ad...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00081627
Start Date
April 1 2004
End Date
January 1 2007
Last Update
November 27 2007
Active Locations (9)
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1
UCSD Moores Cancer Center
La Jolla, California, United States, 92037
2
Mercy General Hospital
Sacramento, California, United States, 95819
3
VA San Diego Healthcare System
San Diego, California, United States, 92161
4
Spectrum Health
Grand Rapids, Michigan, United States, 49503