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Trial record 62 of 722 for:    colon cancer AND 5-FU

Clinical Trial in Patients With Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00235898
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : August 25, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Colon Cancer Rectal Cancer Drug: CoFactor Drug: 5-FU Drug: Leucovorin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2005
Actual Primary Completion Date : March 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
CoFactor, 5-FU
Drug: CoFactor
Other Name: ANX-510

Drug: 5-FU
Other Name: 5-Fluorouracil

Active Comparator: 2
Leucovorin, 5-FU
Drug: 5-FU
Other Name: 5-Fluorouracil

Drug: Leucovorin

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.
  • 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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00235898

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Global Hospital
Hyderabad, Andhra Pradesh, India, 500 004
Department of Medical Oncology, Nizam's Institute of Medical Sciences
Hyderabad, Andhra Pradesh, India, 560 082
Kasturba Medical College
Mangalore, Attavar, India, 575001
Department of Medical Oncology, Deenanath Mangeshkar Hospital and Research Centre
Pune, Erandawane, India, 411004
Department of Medical Oncology, Kidwai Memorial Institute of Oncology
Bangalore, Karnataka, India, 560029
Department of Oncology, Christian Medical College
Vellore, Tamil Nadu, India, 632004
Manipal Hospital
Bangalore, India, 560017
SMS Medical College Hospital
Jaipur, India, 302004
Department of Medical Oncology, Dayanad Medical College and Hospital
Ludhiana, India, 141001
Department of Medical Oncology, Jaslok Hospital and Research Centre
Mumbai, India, 400 026
Colorectal Cancer Clinic, Centrum Cancer Clinic Onkologii-Instytut im M. Skladowskiej-Curie
Roentgena, Warszawa, Poland
Department and Clinic for Oncology and Radiotherapy
Gdansk, Poland, 80-211
Department for Oncology and Radiotherapy, Szpital Morski im. PCK
Gdynia Redlowo, Poland
Oncological Chemotherapy Clinic, Regionalny Osrodek Onkologiczny
Lodz, Poland, 93-509
Oncological Chemotherapy Department Centrum Onkologii Ziemi
Lublin, Poland, 20-090
Clinical Oncology Department, Wojewodski Szpital Zespolony
Torun, Poland, 87-100
Gastroenterology and Hepatology Department, Fundeni Clinical Institute
Bucharest, Romania, 022328
Professor of Dr. Alexandru Trestioreanu, Institute of Oncology II
Bucharest, Romania
Department of Medical Oncology and Radiotherapy II
Cluj-Napoca, Romania, 400015
Medical Oncology Department, County Hospital Sibiu
Sibiu, Romania, 550245
Clinical Center of Serbia
Belgrade, Serbia, 11 000
Institute of Oncology and Radiology Serbia
Belgrade, Serbia, 11 000
CHC Bezanijska
Belgrade, Serbia
CHC Kragujevac
Kragujevac, Serbia, 34000
Clinic Centre Nis
Nis, Serbia, 21104
Clinic for Internal Medicine, Institute for Oncology Sremska
Sremska Kamenica, Serbia, 21104
General Hospital Djordje Joanovic
Zrenjanin, Serbia, 23000
United Kingdom
Haematology/Lung/GI Cancer Services
Harlow, Essex, United Kingdom, CM20 1QX
Oncology Research, North Middlesex University Hospital
Middlesex, London, United Kingdom, N18 1QX
Beatson Oncology Centre
Glasgow, United Kingdom, G11 6NT
Sponsors and Collaborators
Mast Therapeutics, Inc.
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Principal Investigator: James Cassidy, MD Beatson Oncology Centre

Additional Information:
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Responsible Party: Joachim Schupp, MD, Adventrx Pharmaceuticals Identifier: NCT00235898     History of Changes
Other Study ID Numbers: 03-CoFactor
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: August 25, 2008
Last Verified: August 2008
Additional relevant MeSH terms:
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Rectal Neoplasms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Growth Substances