- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00081627
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
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Belgrade, Former Serbia and Montenegro, 11000
- CHC Bezanijska Kosa
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Belgrade, Former Serbia and Montenegro, 11000
- Clinical Center of Serbia
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Belgrade, Former Serbia and Montenegro, 11000
- Institute for Oncology and Radiology Serbia
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Sremska Kamenica, Former Serbia and Montenegro, 21204
- Institute of Oncology
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California
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La Jolla, California, United States, 92037
- UCSD Moores Cancer Center
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Sacramento, California, United States, 95819
- Mercy General Hospital
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San Diego, California, United States, 92161
- VA San Diego Healthcare System
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Michigan
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Grand Rapids, Michigan, United States, 49503
- Spectrum Health
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Texas
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Killeen, Texas, United States, 76549
- Killeen Cancer Center
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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
Collaborators
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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Case Comprehensive Cancer CenterCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer and other conditionsUnited States
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Clinical Trials on CoFactor and 5FU
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Mast Therapeutics, Inc.UnknownBreast CancerArgentina, Mexico, Peru, Russian Federation, Spain
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Hospital Alemão Oswaldo CruzRecruitingRectal Cancer | ConsolidationBrazil, Argentina, Uruguay
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Mast Therapeutics, Inc.CompletedHealthy AdultsUnited States
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AHS Cancer Control AlbertaUnknown
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The Oregon ClinicBristol-Myers Squibb; MedImmune LLCUnknown
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Groupe Oncologie Radiotherapie Tete et CouGustave Roussy, Cancer Campus, Grand ParisCompletedMetastatic or Recurrent Head and Neck Squamous Cell CancerFrance
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ScandiBio Therapeutics ABGöteborg University; Helsinki University Central Hospital; Sahlgrenska University... and other collaboratorsUnknownNon-alcoholic Fatty Liver Disease (NAFLD)Turkey
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AmgenTakedaCompleted
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Andrew Hendifar, MDJanssen Research & Development, LLC; IpsenCompletedPancreatic Cancer | Weight Loss | CachexiaUnited States
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Sixth Affiliated Hospital, Sun Yat-sen UniversityNot yet recruitingPerioperative Combination Chemotherapy Versus Chemoradiation for Locally Advanced EGJ AdenocarcinomaNeoplasms | Esophagogastric Junction Disorder