Clinical Trial in Patients With Metastatic Colorectal Cancer

Phase 2

Completed

• Conditions: Colon Cancer; Rectal Cancer

• Registration Number: NCT00081627
• Lead Sponsor: Mast Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2004-04-15
• Study First Submitted QC: 2004-10-13
• Study First Posted: 2004-10-14
• Study Completion: 2007-01
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-26
• Last Update Posted: 2007-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (9)

Mercy General Hospital; 🇺🇸 Sacramento, California, United States

Killeen Cancer Center; 🇺🇸 Killeen, Texas, United States

Institute of Oncology; Sremska Kamenica, Former Serbia and Montenegro

CHC Bezanijska Kosa; Belgrade, Former Serbia and Montenegro

UCSD Moores Cancer Center; 🇺🇸 La Jolla, California, United States

VA San Diego Healthcare System; 🇺🇸 San Diego, California, United States

Spectrum Health; 🇺🇸 Grand Rapids, Michigan, United States

Clinical Center of Serbia; Belgrade, Former Serbia and Montenegro

Institute for Oncology and Radiology Serbia; Belgrade, Former Serbia and Montenegro