Clinical Trial in Patients With Metastatic Colorectal Cancer
- Conditions
- Colon CancerRectal Cancer
- Interventions
- Registration Number
- NCT00235898
- Lead Sponsor
- Mast Therapeutics, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- Have surgically incurable, confirmed metastatic colon or rectal adenocarcinoma.
- Be male or non-pregnant, non-lactating female subjects โฅ 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.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 CoFactor CoFactor, 5-FU 1 5-FU CoFactor, 5-FU 2 Leucovorin Leucovorin, 5-FU 2 5-FU Leucovorin, 5-FU
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
Department of Oncology, Christian Medical College
๐ฎ๐ณVellore, Tamil Nadu, India
Global Hospital
๐ฎ๐ณHyderabad, Andhra Pradesh, India
Clinic for Internal Medicine, Institute for Oncology Sremska
๐ท๐ธSremska Kamenica, Serbia
Oncology Research, North Middlesex University Hospital
๐ฌ๐งMiddlesex, London, United Kingdom
Department and Clinic for Oncology and Radiotherapy
๐ต๐ฑGdansk, Poland
General Hospital Djordje Joanovic
๐ท๐ธZrenjanin, Serbia
Haematology/Lung/GI Cancer Services
๐ฌ๐งHarlow, Essex, United Kingdom
Professor of Dr. Alexandru Trestioreanu, Institute of Oncology II
๐ท๐ดBucharest, Romania
CHC Kragujevac
๐ท๐ธKragujevac, Serbia
Medical Oncology Department, County Hospital Sibiu
๐ท๐ดSibiu, Romania
Institute of Oncology and Radiology Serbia
๐ท๐ธBelgrade, Serbia
Beatson Oncology Centre
๐ฌ๐งGlasgow, United Kingdom
CHC Bezanijska
๐ท๐ธBelgrade, Serbia
SMS Medical College Hospital
๐ฎ๐ณJaipur, India
Clinical Oncology Department, Wojewodski Szpital Zespolony
๐ต๐ฑTorun, Poland
Department of Medical Oncology and Radiotherapy II
๐ท๐ดCluj-Napoca, Romania
Clinic Centre Nis
๐ท๐ธNis, Serbia
Manipal Hospital
๐ฎ๐ณBangalore, India
Oncological Chemotherapy Clinic, Regionalny Osrodek Onkologiczny
๐ต๐ฑLodz, Poland
Clinical Center of Serbia
๐ท๐ธBelgrade, Serbia
Department of Medical Oncology, Nizam's Institute of Medical Sciences
๐ฎ๐ณHyderabad, Andhra Pradesh, India
Department of Medical Oncology, Kidwai Memorial Institute of Oncology
๐ฎ๐ณBangalore, Karnataka, India
Department of Medical Oncology, Jaslok Hospital and Research Centre
๐ฎ๐ณMumbai, India
Department for Oncology and Radiotherapy, Szpital Morski im. PCK
๐ต๐ฑGdynia Redlowo, Poland
Oncological Chemotherapy Department Centrum Onkologii Ziemi
๐ต๐ฑLublin, Poland
Kasturba Medical College
๐ฎ๐ณMangalore, Attavar, India
Department of Medical Oncology, Deenanath Mangeshkar Hospital and Research Centre
๐ฎ๐ณPune, Erandawane, India
Department of Medical Oncology, Dayanad Medical College and Hospital
๐ฎ๐ณLudhiana, India
Colorectal Cancer Clinic, Centrum Cancer Clinic Onkologii-Instytut im M. Skladowskiej-Curie
๐ต๐ฑRoentgena, Warszawa, Poland
Gastroenterology and Hepatology Department, Fundeni Clinical Institute
๐ท๐ดBucharest, Romania