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5-Fluorouracil Combined With CoFactor (5-10 Methylenetetrahydrofolate) in Treating Advanced Breast Cancer Patients

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.
 
ClinicalTrials.gov Identifier: NCT00434369
Recruitment Status : Unknown
Verified April 2008 by Mast Therapeutics, Inc..
Recruitment status was:  Active, not recruiting
First Posted : February 13, 2007
Last Update Posted : April 22, 2008
Sponsor:
Information provided by:
Mast Therapeutics, Inc.

Brief Summary:
A multi-center, open-label, single-arm Phase II trial assessing the efficacy and safety of weekly bolus infusions of 5-fluorouracil combined with CoFactor (5-10 methylenetetrahydrofolate) in advanced breast cancer patients who failed anthracycline and taxane chemotherapy regimens.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: CoFactor (ANX-510) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Open-Label, Single-Arm Phase II Trial Assessing the Efficacy and Safety of Weekly Bolus Infusions of 5-Fluorouracil Combined With CoFactor (5-10 Methylenetetrahydrofolate) in Advanced Breast Cancer Patients Who Failed Anthracycline and Taxane Chemotherapy Regimens
Study Start Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer




Primary Outcome Measures :
  1. Overall Response Rate

Secondary Outcome Measures :
  1. Progression Free Survival
  2. Overall Survival
  3. Duration of Response


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Signed informed consent.
  • Women with a histologically/cytologically proven diagnosis of advanced adenocarcinoma of the breast.
  • Measurable disease. At least one unidimensionally measurable non-bony lesion with a diameter >=10 mm using spiral CT scans (use of spiral CT must be documented in medical records and used consistently throughout the study) or >= 20 mm using conventional CT or MRI scans outside the irradiated area according to RECIST criteria.
  • Patients having failed both prior anthracycline and taxane derivative chemotherapy regimens. Anthrocycline and Taxane failure definitions as defined in the protocol.
  • No more than two prior chemotherapy regimens for advanced disease.
  • Performance status (ECOG) <= 2 or Karnofsky >= 70
  • Age >= 18 years.
  • Life expectancy >= 12 weeks.
  • Adequate organ function as shown by the following:

    1. WBCs >= 3.0 x 109/L, absolute neutrophil count (ANC)>= 1.5 x 109/L, platelets >= 100 x 109/L, hemoglobin >= 9 g/dL
    2. Bilirubin <= 1.25 x the upper limit of normal (ULN),aspartate aminotransferase(AST or alanine aminotransferase(ALT),= 3 x ULN (or <= 5 x ULN in case of liver metastases)
    3. Serum calcium within normal limits
    4. Serum albumin within the normal range for the study site
    5. Creatinine clearance >= 60 mL/min (Cockroft and Gault)
    6. Left ventricular ejection fraction (LVEF) within normal limits as shown by echocardiography or scintigraphy (multiple-gated acquisition scan).
  • Patients of childbearing potential must be using medically acceptable contraception for 4 weeks before start of study treatment and 4 months after study treatment completion. Patients of childbearing potential must have a negative pregnancy test result within 7 days prior to study treatment initiation.
  • Patients with parenchymal brain metastases must be either adequately controlled following resection or completed appropriate radiation therapy and be receiving a stable corticosteroid dose prior to study entry. Patients with leptomeningeal involvement should not be included in the study.

Exclusion Criteria:

  • Her2/neu positive tumor (2+ or 3+).
  • Pregnancy or lactation
  • Systemic cytotoxic anti-cancer therapy within <=4 weeks of study entry, or 6 weeks if the systemic therapy contains a nitrosourea or mitomycin C. Hormonal anti-cancer treatment must be ongoing, or must have been discontinued >3 months before study entry.
  • Prior 5-FU- and/or capecitabine-based palliative chemotherapy.
  • Extensive prior radiotherapy affecting more than 30% of bone marrow reserves, or bone marrow / stem cell transplantation.
  • Participation in clinical studies of non-approved experimental agents or procedures within <=4 weeks of study entry.
  • History of other malignancy, unless cured and the patient has been disease-free for >=2 years. Patients with a history of cervical carcinoma in situ or cured stage I cervical cancer, or of epidermal or basal cell skin cancer, may be eligible for enrollment after discussion with the sponsor.
  • Previous unexpected reaction to fluoropyrimidines, with or without documented deficiency of dihydropyrimidine dehydrogenase, or known hypersensitivity to 5-FU.
  • Psychologic, familial, sociologic or geographic conditions which do not permit compliance with the study protocol and/or study.
  • Significant cardiac disease, including symptomatic ventricular arrhythmia, congestive heart failure, myocardial infarction within 12 months before study entry.
  • Concomitant treatment with any experimental drug or anti-cancer drug, except hormone therapy or bisphosphonates.

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 ClinicalTrials.gov identifier (NCT number): NCT00434369


Locations
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Argentina
Clinical Research Site in
Buenos Aires, Argentina
Mexico
Clinical Investigative Site
Acapulco, Mexico
Peru
Clinical Investigative Site
Lima, Peru
Russian Federation
Clinical Research Site in
Kazan, Russian Federation
Clinical Investigative Site
St.Petersburg, Russian Federation
Spain
Clinical Investigative Site
Valencia, Spain
Sponsors and Collaborators
Mast Therapeutics, Inc.

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ClinicalTrials.gov Identifier: NCT00434369    
Other Study ID Numbers: 510-08
First Posted: February 13, 2007    Key Record Dates
Last Update Posted: April 22, 2008
Last Verified: April 2008
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tetrahydrofolates
Fluorouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances