Clinical Trial in Patients With Metastatic Colorectal Cancer

August 22, 2008 updated by: Mast Therapeutics, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
CoFactor, 5-FU
Drug: 5-FU
Other Names:
  • 5-Fluorouracil
Drug: CoFactor
Other Names:
  • ANX-510
Active Comparator: 2
Leucovorin, 5-FU
Drug: Leucovorin
Drug: 5-FU
Other Names:
  • 5-Fluorouracil

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mast Therapeutics, Inc.

Investigators

  • Principal Investigator: James Cassidy, MD, Beatson Oncology Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

October 6, 2005

First Submitted That Met QC Criteria

October 10, 2005

First Posted (Estimate)

October 12, 2005

Study Record Updates

Last Update Posted (Estimate)

August 25, 2008

Last Update Submitted That Met QC Criteria

August 22, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-CoFactor

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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