COFU: A Multi-Center Phase II Clinical Trial to Evaluate the Safety and Efficacy of Weekly Treatment With CoFactor and 5-Fluorouracil in Patients With Metastatic Colorectal Carcinoma
Data Collection
Colonic Diseases+10
+ Colonic Neoplasms
+ Digestive System Diseases
Treatment Study
Summary
Study start date: April 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.48 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 9 locations
Mercy General Hospital
Sacramento, United StatesVA San Diego Healthcare System
San Diego, United StatesSpectrum Health
Grand Rapids, United States