Clinical Trial in Patients With Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by:
Mast Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00235898
First received: October 6, 2005
Last updated: August 22, 2008
Last verified: August 2008
  Purpose

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 Intervention Phase
Colon Cancer
Rectal Cancer
Drug: CoFactor
Drug: 5-FU
Drug: Leucovorin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Mast Therapeutics, Inc.:

Enrollment: 300
Study Start Date: May 2005
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00235898

Locations
India
Department of Medical Oncology, Nizam's Institute of Medical Sciences
Hyderabad, Andhra Pradesh, India, 560 082
Global Hospital
Hyderabad, Andhra Pradesh, India, 500 004
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
Poland
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
Romania
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
Serbia
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.
Investigators
Principal Investigator: James Cassidy, MD Beatson Oncology Centre
  More Information

Additional Information:
No publications provided

Responsible Party: Joachim Schupp, MD, Adventrx Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00235898     History of Changes
Other Study ID Numbers: 03-CoFactor
Study First Received: October 6, 2005
Last Updated: August 22, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Romania: Ministry of Public Health
Poland: Ministry of Health
India: Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices

Additional relevant MeSH terms:
Colonic Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes

ClinicalTrials.gov processed this record on April 23, 2014