Colon CancerPhase 2NCT00235898
Clinical Trial in Patients With Metastatic Colorectal Cancer
A Phase 2 study testing CoFactor, 5-FU and Leucovorin in people with Colon Cancer and Rectal Cancer, run by Mast Therapeutics, Inc. at 30 sites in 5 countries.
Trial summary
The objective of this trial is to compare efficacy and safety of CoFactor and 5-fluorouracil (5-FU) versus leucovorin and 5-FU in treatment of metastatic colorectal cancer. 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, 5-FU and Leucovorin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 30 sitesin 5 countries
- Study dates
- May 2005to Mar 2008
- 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
- Have surgically incurable, confirmed metastatic colon or rectal adenocarcinoma.
- Be male or non-pregnant, non-lactating female subjects ≥ 18 years of age.
- If female, and of childbearing potential, agree to use adequate contraception (as deemed by the investigator) throughout their participation in this study and for 30 days after discontinuation of study medication.
- If, female of childbearing potential, have a negative pregnancy test prior to the start of the study.
- Have a life expectancy of at least 6 months.
- Have radiologically or clinically measurable disease for response assessment. Presence of ascites or pleural effusion(s) are not acceptable as single sites of response assessment, but may be present if dimensional or other discrete measurable disease is present for evaluation.
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- Have an ECOG Performance Level of 0-2 (or Karnofsky of 100-70). A lower ECOG or Karnofsky is acceptable only if clearly due to non-oncologic conditions (e.g., prior paraplegia from polio).
- Have had no prior chemotherapy for established, metastatic disease. (Subjects may have received adjuvant chemotherapy with fluoropyrimidine therapy).
- Have at least 6 months elapsed since prior adjuvant 5-FU or CPT-11 therapy, or Mitomycin C or nitrosourea therapy.
- Have had at least an 8 week interval since any prior radiation therapy or 4 weeks since any major surgery.
- Have recovered from any toxicities resulting from prior therapies (except for alopecia).
- Adequate renal, bone marrow, liver function defined as serum creatinine less than 1.5 times the upper limit of normal, serum bilirubin less than 2 times the upper limit of normal, ANC greater than 1.5 x 109/L, Platelet count greater than 90 x 109/L, SGOT (AST) and SGPT (ALT) less than 3 times the upper limit of normal.
Who cannot join
- Failure by the subject or the subject's legal representative to sign the Informed Consent.
- An inability to obtain Informed Consent because of psychiatric or complex medical problems.
- Have concurrent infection including diagnoses of FUO or evidence of possible central line sepsis (subjects must be afebrile at the start of therapy).
- Have unstable oncologic emergency syndromes: superior vena cava (SVC) syndrome, rising bilirubin needing stent placement, spinal cord compression, progressive brain metastases, active bleeding, hypercalcemia, etc.
- Have unstable medical conditions such as acute coronary syndrome, cardio-vascular accident within the previous 12 months (such as transient ischemic attacks, accelerated hypertension), etc.
- Have cerebellar neurologic syndromes such as Parkinson's disease, multiple sclerosis, and amyotonia.
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- Have a known intolerance to fluoropyrimidine (5-FU, Capecitabine, Floxuridine, UFT) therapy (dihydropyrimidine dehydrogenase deficiency).
- Patients with vomiting, diarrhea, or nausea of grade greater than 1.
- Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug.
Trial locations and contacts
30 sites in 5 countries.
30 sites in 5 countries
India10 sites
Department of Medical Oncology, Kidwai Memorial Institute of Oncology
Bangalore, Karnataka, 560029
Manipal Hospital
Bangalore, 560017
Global Hospital
Hyderabad, Andhra Pradesh, 500 004
Department of Medical Oncology, Nizam's Institute of Medical Sciences
Hyderabad, Andhra Pradesh, 560 082
SMS Medical College Hospital
Jaipur, 302004
Department of Medical Oncology, Dayanad Medical College and Hospital
Ludhiana, 141001
Kasturba Medical College
Mangalore, Attavar, 575001
Department of Medical Oncology, Jaslok Hospital and Research Centre
Mumbai, 400 026
Department of Medical Oncology, Deenanath Mangeshkar Hospital and Research Centre
Pune, Erandawane, 411004
Department of Oncology, Christian Medical College
Vellore, Tamil Nadu, 632004
Serbia7 sites
Clinical Center of Serbia
Belgrade, 11 000
Institute of Oncology and Radiology Serbia
Belgrade, 11 000
CHC Bezanijska
Belgrade
Clinic for Internal Medicine, Institute for Oncology Sremska
Kamenitz, 21104
CHC Kragujevac
Kragujevac, 34000
Clinic Centre Nis
Niš, 21104
General Hospital Djordje Joanovic
Zrenjanin, 23000
Poland6 sites
Department and Clinic for Oncology and Radiotherapy
Gdansk, 80-211
Department for Oncology and Radiotherapy, Szpital Morski im. PCK
Gdynia Redlowo
Oncological Chemotherapy Clinic, Regionalny Osrodek Onkologiczny
Lodz, 93-509
Oncological Chemotherapy Department Centrum Onkologii Ziemi
Lublin, 20-090
Colorectal Cancer Clinic, Centrum Cancer Clinic Onkologii-Instytut im M. Skladowskiej-Curie
Roentgena, Warszawa
Clinical Oncology Department, Wojewodski Szpital Zespolony
Torun, 87-100
Romania4 sites
Gastroenterology and Hepatology Department, Fundeni Clinical Institute
Bucharest, 022328
Professor of Dr. Alexandru Trestioreanu, Institute of Oncology II
Bucharest
Department of Medical Oncology and Radiotherapy II
Cluj-Napoca, 400015
Medical Oncology Department, County Hospital Sibiu
Sibiu, 550245
United Kingdom3 sites
Beatson Oncology Centre
Glasgow, G11 6NT
Haematology/Lung/GI Cancer Services
Harlow, Essex, CM20 1QX
Oncology Research, North Middlesex University Hospital
Middlesex, London, N18 1QX
About this study
Official title: A Multi-Center, Open Label, Parallel Group, Randomised, Phase IIB Clinical Trial to Evaluate the Safety and Efficacy of CoFactor and 5-FU Versus Leucovorin and 5-FU in Subjects With Metastatic Colorectal Carcinoma
The objective of this trial is to compare efficacy and safety of CoFactor and 5-fluorouracil (5-FU) versus leucovorin and 5-FU in treatment of metastatic colorectal cancer.
- Conditions
- Colon Cancer, Rectal Cancer
- Being tested
- CoFactor, 5-FU, Leucovorin
- 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.
CoFactorDrug
Also called ANX-510
5-FUDrug
Also called 5-Fluorouracil
LeucovorinDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CoFactor, 5-FU Receives: Drug: CoFactor; Drug: 5-FU |
| 2 | Active comparator | Leucovorin, 5-FU Receives: Drug: 5-FU; Drug: Leucovorin |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startMay 2005
- Primary completionMar 2008
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mast Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James Cassidy, MD, Principal investigator, Beatson Oncology Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235898
- Sponsor's protocol ID
- 03-CoFactor
- Status last verified
- Aug 2008
- First submitted
- 6 Oct 2005
- Last updated
- 25 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open Label, Parallel Group, Randomised, Phase IIB Clinical Trial to Evaluate the Safety and Efficacy of CoFactor and 5-FU Versus Leucovorin and 5-FU in Subjects With Metastatic Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT00235898
- Acronym / sponsor ID
- 03-CoFactor
- Conditions
- Colon Cancer, Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Mast Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Mar 2008 (actual)
- First posted
- 12 Oct 2005 (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 objective of this trial is to compare efficacy and safety of CoFactor and 5-fluorouracil (5-FU) versus leucovorin and 5-FU in treatment of metastatic colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CoFactor, Drug: 5-FUCoFactor, 5-FU |
| 2 | Active comparator | Drug: 5-FU, Drug: LeucovorinLeucovorin, 5-FU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Have surgically incurable, confirmed metastatic colon or rectal adenocarcinoma.
- Be male or non-pregnant, non-lactating female subjects ≥ 18 years of age.
- If female, and of childbearing potential, agree to use adequate contraception (as deemed by the investigator) throughout their participation in this study and for 30 days after discontinuation of study medication.
- If, female of childbearing potential, have a negative pregnancy test prior to the start of the study.
- Have a life expectancy of at least 6 months.
Key exclusion criteria (9 listed)
- Failure by the subject or the subject's legal representative to sign the Informed Consent.
- An inability to obtain Informed Consent because of psychiatric or complex medical problems.
- Have concurrent infection including diagnoses of FUO or evidence of possible central line sepsis (subjects must be afebrile at the start of therapy).
- Have unstable oncologic emergency syndromes: superior vena cava (SVC) syndrome, rising bilirubin needing stent placement, spinal cord compression, progressive brain metastases, active bleeding, hypercalcemia, etc.
- Have unstable medical conditions such as acute coronary syndrome, cardio-vascular accident within the previous 12 months (such as transient ischemic attacks, 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 |
|---|---|---|
| CoFactorAlso: ANX-510 | Drug | 1 |
| 5-FUAlso: 5-Fluorouracil | Drug | 1, 2 |
| Leucovorin | Drug | 2 |
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 25 Aug 2008.
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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.
James Cassidy, MD principal investigator
Beatson Oncology Centre
30 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CoFactor, 5-FU and Leucovorin in people with Colon Cancer and Rectal Cancer, run by Mast Therapeutics, Inc. at 30 sites in 5 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 12 inclusion and 9 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 25 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in India, Serbia, Poland, Romania, United Kingdom. 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 25 Aug 2008.