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Trial record 84 of 186 for:    colon cancer | ( Map: Texas, United States )

Clinical Trial in Patients With Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00081627
Recruitment Status : Completed
First Posted : October 14, 2004
Last Update Posted : November 27, 2007
University of California, San Diego
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Colon Cancer Rectal Cancer Drug: CoFactor and 5FU Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2004
Actual Study Completion Date : January 2007

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00081627

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United States, California
UCSD Moores Cancer Center
La Jolla, California, United States, 92037
Mercy General Hospital
Sacramento, California, United States, 95819
VA San Diego Healthcare System
San Diego, California, United States, 92161
United States, Michigan
Spectrum Health
Grand Rapids, Michigan, United States, 49503
United States, Texas
Killeen Cancer Center
Killeen, Texas, United States, 76549
Former Serbia and Montenegro
CHC Bezanijska Kosa
Belgrade, Former Serbia and Montenegro, 11000
Clinical Center of Serbia
Belgrade, Former Serbia and Montenegro, 11000
Institute for Oncology and Radiology Serbia
Belgrade, Former Serbia and Montenegro, 11000
Institute of Oncology
Sremska Kamenica, Former Serbia and Montenegro, 21204
Sponsors and Collaborators
Mast Therapeutics, Inc.
University of California, San Diego
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Principal Investigator: Tony Reid, MD, PhD University of California, San Diego

Additional Information:
Layout table for additonal information Identifier: NCT00081627    
Other Study ID Numbers: 02-CoFactor
First Posted: October 14, 2004    Key Record Dates
Last Update Posted: November 27, 2007
Last Verified: November 2007
Additional relevant MeSH terms:
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Rectal Neoplasms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs