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

NCT00434369 | Unknown Phase 2

• 1 other identifier: 510-08
• Study Type: interventional
• Target: 31
• Locations: 5 countries
• Sites: 6

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

Secondary Outcomes (3)

• Progression Free Survival

• Overall Survival

• Duration of Response

Interventions

CoFactor (ANX-510) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• WBCs \>= 3.0 x 109/L, absolute neutrophil count (ANC)\>= 1.5 x 109/L, platelets \>= 100 x 109/L, hemoglobin \>= 9 g/dL
• 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)
• Serum calcium within normal limits
• Serum albumin within the normal range for the study site
• Creatinine clearance \>= 60 mL/min (Cockroft and Gault)
• Left ventricular ejection fraction (LVEF) within normal limits as shown by echocardiography or scintigraphy (multiple-gated acquisition scan).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mast Therapeutics, Inc.: lead

Study Sites (6)

Clinical Research Site in

Buenos Aires, Argentina

Location

Clinical Investigative Site

Acapulco, Mexico

Location

Clinical Investigative Site

Lima, Peru

Location

Clinical Research Site in

Kazan', Russia

Location

Clinical Investigative Site

Saint Petersburg, Russia

Location

Clinical Investigative Site

Valencia, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

5,11-methenyltetrahydrohomofolate

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 7, 2007
• First Posted: February 13, 2007
• Study Start: February 1, 2006
• Last Updated: April 22, 2008

Record last verified: 2008-04

Locations

ES (1); PE (1); ME (1); AR (1); RU (2)