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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. 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
Information provided by:
Mast Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE February 7, 2007
First Posted Date  ICMJE February 13, 2007
Last Update Posted Date April 22, 2008
Study Start Date  ICMJE February 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2007)
Overall Response Rate
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2007)
  • Progression Free Survival
  • Overall Survival
  • Duration of Response
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE 5-Fluorouracil Combined With CoFactor (5-10 Methylenetetrahydrofolate) in Treating Advanced Breast Cancer Patients
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Drug: CoFactor (ANX-510)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 9, 2007)
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Mexico,   Peru,   Russian Federation,   Spain
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00434369
Other Study ID Numbers  ICMJE 510-08
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Mast Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mast Therapeutics, Inc.
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP