Clinical Trial in Patients With Metastatic Colorectal Cancer
NCT ID: NCT00081627
Last Updated: 2007-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2004-04-30
2007-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CoFactor and 5FU
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of California, San Diego
OTHER
Mast Therapeutics, Inc.
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tony Reid, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UCSD Moores Cancer Center
La Jolla, California, United States
Mercy General Hospital
Sacramento, California, United States
VA San Diego Healthcare System
San Diego, California, United States
Spectrum Health
Grand Rapids, Michigan, United States
Killeen Cancer Center
Killeen, Texas, United States
CHC Bezanijska Kosa
Belgrade, , Serbia and Montenegro
Clinical Center of Serbia
Belgrade, , Serbia and Montenegro
Institute for Oncology and Radiology Serbia
Belgrade, , Serbia and Montenegro
Institute of Oncology
Sremska Kamenica, , Serbia and Montenegro
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
02-CoFactor
Identifier Type: -
Identifier Source: org_study_id