Clinical Trial in Patients With Metastatic Colorectal Cancer
NCT ID: NCT00235898
Last Updated: 2008-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
300 participants
INTERVENTIONAL
2005-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
CoFactor, 5-FU
CoFactor
5-FU
2
Leucovorin, 5-FU
5-FU
Leucovorin
Interventions
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CoFactor
5-FU
Leucovorin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
* 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.
18 Years
ALL
No
Sponsors
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Mast Therapeutics, Inc.
INDUSTRY
Responsible Party
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Adventrx Pharmaceuticals
Principal Investigators
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James Cassidy, MD
Role: PRINCIPAL_INVESTIGATOR
Beatson Oncology Centre
Locations
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Global Hospital
Hyderabad, Andhra Pradesh, India
Department of Medical Oncology, Nizam's Institute of Medical Sciences
Hyderabad, Andhra Pradesh, India
Kasturba Medical College
Mangalore, Attavar, India
Department of Medical Oncology, Deenanath Mangeshkar Hospital and Research Centre
Pune, Erandawane, India
Department of Medical Oncology, Kidwai Memorial Institute of Oncology
Bangalore, Karnataka, India
Department of Oncology, Christian Medical College
Vellore, Tamil Nadu, India
Manipal Hospital
Bangalore, , India
SMS Medical College Hospital
Jaipur, , India
Department of Medical Oncology, Dayanad Medical College and Hospital
Ludhiana, , India
Department of Medical Oncology, Jaslok Hospital and Research Centre
Mumbai, , India
Colorectal Cancer Clinic, Centrum Cancer Clinic Onkologii-Instytut im M. Skladowskiej-Curie
Roentgena, Warszawa, Poland
Department and Clinic for Oncology and Radiotherapy
Gdansk, , Poland
Department for Oncology and Radiotherapy, Szpital Morski im. PCK
Gdynia Redlowo, , Poland
Oncological Chemotherapy Clinic, Regionalny Osrodek Onkologiczny
Lodz, , Poland
Oncological Chemotherapy Department Centrum Onkologii Ziemi
Lublin, , Poland
Clinical Oncology Department, Wojewodski Szpital Zespolony
Torun, , Poland
Gastroenterology and Hepatology Department, Fundeni Clinical Institute
Bucharest, , Romania
Professor of Dr. Alexandru Trestioreanu, Institute of Oncology II
Bucharest, , Romania
Department of Medical Oncology and Radiotherapy II
Cluj-Napoca, , Romania
Medical Oncology Department, County Hospital Sibiu
Sibiu, , Romania
Clinical Center of Serbia
Belgrade, , Serbia
Institute of Oncology and Radiology Serbia
Belgrade, , Serbia
CHC Bezanijska
Belgrade, , Serbia
Clinic for Internal Medicine, Institute for Oncology Sremska
Kamenitz, , Serbia
CHC Kragujevac
Kragujevac, , Serbia
Clinic Centre Nis
Niš, , Serbia
General Hospital Djordje Joanovic
Zrenjanin, , Serbia
Haematology/Lung/GI Cancer Services
Harlow, Essex, United Kingdom
Oncology Research, North Middlesex University Hospital
Middlesex, London, United Kingdom
Beatson Oncology Centre
Glasgow, , United Kingdom
Countries
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Other Identifiers
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03-CoFactor
Identifier Type: -
Identifier Source: org_study_id