Clinical Trial in Patients With Metastatic Colorectal Cancer

Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00081627
• Other study ID #: 02-CoFactor
• Status: Completed
• Phase: Phase 2
• First received: April 15, 2004
• Last updated: November 26, 2007
• Start date: April 2004
• Est. completion date: January 2007

Study information

• Verified date: November 2007
• Source: Mast Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colon Cancer
• Rectal Cancer

Intervention

Drug:
• CoFactor and 5FU

Locations

Country	Name	City	State
Former Serbia and Montenegro	CHC Bezanijska Kosa	Belgrade
Former Serbia and Montenegro	Clinical Center of Serbia	Belgrade
Former Serbia and Montenegro	Institute for Oncology and Radiology Serbia	Belgrade
Former Serbia and Montenegro	Institute of Oncology	Sremska Kamenica
United States	Spectrum Health	Grand Rapids	Michigan
United States	Killeen Cancer Center	Killeen	Texas
United States	UCSD Moores Cancer Center	La Jolla	California
United States	Mercy General Hospital	Sacramento	California
United States	VA San Diego Healthcare System	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Mast Therapeutics, Inc.	University of California, San Diego

Countries where clinical trial is conducted

United States,  Former Serbia and Montenegro, 

External Links

•   Sponsor website