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

Phase 2

• Conditions: Breast Cancer

• Registration Number: NCT00434369
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2007-02-07
• Study First Submitted QC: 2007-02-09
• Study First Posted: 2007-02-13
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-18
• Last Update Posted: 2008-04-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall Response Rate

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival
Overall Survival
Duration of Response

Trial Locations

Locations (2)

Clinical Research Site in; 🇷🇺 Kazan, Russian Federation

Clinical Investigative Site; 🇪🇸 Valencia, Spain