Clinical Trial in Patients With Metastatic Colorectal Cancer

November 26, 2007 updated by: Mast Therapeutics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Former Serbia and Montenegro
      • Belgrade, Former Serbia and Montenegro, 11000
        • 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
      • Sremska Kamenica, Former Serbia and Montenegro, 21204
        • Institute of Oncology
  • United States
    • California
      • La Jolla, California, United States, 92037
        • UCSD Moores Cancer Center
      • Sacramento, California, United States, 95819
        • Mercy General Hospital
      • San Diego, California, United States, 92161
        • VA San Diego Healthcare System
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health
    • Texas
      • Killeen, Texas, United States, 76549
        • Killeen Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mast Therapeutics, Inc.

Collaborators

University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

April 15, 2004

First Submitted That Met QC Criteria

October 13, 2004

First Posted (Estimate)

October 14, 2004

Study Record Updates

Last Update Posted (Estimate)

November 27, 2007

Last Update Submitted That Met QC Criteria

November 26, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-CoFactor

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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