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Clinical Trial in Patients With Metastatic Colorectal Cancer

Primary Purpose

Colon Cancer, Rectal Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CoFactor and 5FU
Sponsored by
Mast Therapeutics, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCSD Moores Cancer Center
  • Mercy General Hospital
  • VA San Diego Healthcare System
  • Spectrum Health
  • Killeen Cancer Center
  • CHC Bezanijska Kosa
  • Clinical Center of Serbia
  • Institute for Oncology and Radiology Serbia
  • Institute of Oncology

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 15, 2004
Last Updated
November 26, 2007
Sponsor
Mast Therapeutics, Inc.
Collaborators
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT00081627
Brief Title
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

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mast Therapeutics, Inc.
Collaborators
University of California, San Diego

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Rectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CoFactor and 5FU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tony Reid, MD, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Mercy General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
VA San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Killeen Cancer Center
City
Killeen
State/Province
Texas
ZIP/Postal Code
76549
Country
United States
Facility Name
CHC Bezanijska Kosa
City
Belgrade
ZIP/Postal Code
11000
Country
Former Serbia and Montenegro
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Former Serbia and Montenegro
Facility Name
Institute for Oncology and Radiology Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Former Serbia and Montenegro
Facility Name
Institute of Oncology
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Former Serbia and Montenegro

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial in Patients With Metastatic Colorectal Cancer

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