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5-Fluorouracil Combined With CoFactor (5-10 Methylenetetrahydrofolate) in Treating Advanced Breast Cancer Patients
This study is ongoing, but not recruiting participants.
First Received: February 7, 2007   Last Updated: April 18, 2008   History of Changes
Sponsored by: Adventrx Pharmaceuticals
Information provided by: Adventrx Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00434369
  Purpose

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 Intervention Phase
Breast Cancer
Drug: CoFactor (ANX-510)
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Fluorouracil
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Adventrx Pharmaceuticals:

Primary Outcome Measures:
  • Overall Response Rate

Secondary Outcome Measures:
  • Progression Free Survival
  • Overall Survival
  • Duration of Response

Estimated Enrollment: 31
Study Start Date: February 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00434369

Locations
Argentina
Clinical Research Site in
Buenos Aires, Argentina
Mexico
Clinical Investigative Site
Acapulco, Mexico
Peru
Clinical Investigative Site
Lima, Peru
Russian Federation
Clinical Investigative Site
St.Petersburg, Russian Federation
Clinical Research Site in
Kazan, Russian Federation
Spain
Clinical Investigative Site
Valencia, Spain
Sponsors and Collaborators
Adventrx Pharmaceuticals
  More Information

No publications provided

Study ID Numbers: 510-08
Study First Received: February 7, 2007
Last Updated: April 18, 2008
ClinicalTrials.gov Identifier: NCT00434369     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Antimetabolites
Hydroxyzine
Immunologic Factors
Skin Diseases
Fluorouracil
Breast Neoplasms
Immunosuppressive Agents
Taxane
Breast Diseases

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Breast Neoplasms
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Fluorouracil
Therapeutic Uses
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009