Colon CancerPhase 2NCT00081627
Clinical Trial in Patients With Metastatic Colorectal Cancer
A Phase 2 study testing CoFactor and 5FU in people with Colon Cancer and Rectal Cancer, run by Mast Therapeutics, Inc. at 9 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Rectal Cancer
- What is being tested?
- CoFactor and 5FU
- How many people
- 48 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Apr 2004to Jan 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States5 sites
Spectrum Health
Grand Rapids, Michigan, 49503
Killeen Cancer Center
Killeen, Texas, 76549
UCSD Moores Cancer Center
La Jolla, California, 92037
Mercy General Hospital
Sacramento, California, 95819
VA San Diego Healthcare System
San Diego, California, 92161
Serbia and Montenegro4 sites
CHC Bezanijska Kosa
Belgrade, 11000
Clinical Center of Serbia
Belgrade, 11000
Institute for Oncology and Radiology Serbia
Belgrade, 11000
Institute of Oncology
Sremska Kamenica, 21204
About this study
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
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.
- Conditions
- Colon Cancer, Rectal Cancer
- Being tested
- CoFactor and 5FU
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoFactor and 5FUDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2004 (estimated)
- Study startApr 2004
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants
Sponsor and investigators
- Lead sponsor
- Mast Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Diego
- Investigators
- Tony Reid, MD, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00081627
- Sponsor's protocol ID
- 02-CoFactor
- Status last verified
- Nov 2007
- First submitted
- 15 Apr 2004
- Last updated
- 27 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00081627
- Acronym / sponsor ID
- 02-CoFactor
- Conditions
- Colon Cancer, Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants
- Lead sponsor
- Mast Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Diego
- Study start
- Apr 2004
- Study completion
- Jan 2007 (actual)
- First posted
- 14 Oct 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoFactor and 5FU | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tony Reid, MD, PhD principal investigator
University of California, San Diego
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CoFactor and 5FU in people with Colon Cancer and Rectal Cancer, run by Mast Therapeutics, Inc. at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Serbia and Montenegro. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2007.