Clinical trial NCT00081627: Clinical Trial in Patients With Metastatic Colorectal Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colon Cancer
Rectal Cancer
Lead sponsor: Mast Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Diego
First posted: 2004-10-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 administration of CoFactor and 5-FU.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Killeen
country: United States
facility: Killeen Cancer Center
state: Texas
city: Belgrade
country: Former Serbia and Montenegro
facility: CHC Bezanijska Kosa
city: Belgrade
country: Former Serbia and Montenegro
facility: Clinical Center of Serbia
city: Belgrade
country: Former Serbia and Montenegro
facility: Institute for Oncology and Radiology Serbia
city: Sremska Kamenica
country: Former Serbia and Montenegro
facility: Institute of Oncology
Study officials:
affiliation: University of California, San Diego
name: Tony Reid, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: