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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00434369
• Other study ID #: 510-08
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 7, 2007
• Last updated: April 18, 2008
• Start date: February 2006

Study information

• Verified date: April 2008
• Source: Mast Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• CoFactor (ANX-510)

Locations

Country	Name	City	State
Argentina	Clinical Research Site in	Buenos Aires
Mexico	Clinical Investigative Site	Acapulco
Peru	Clinical Investigative Site	Lima
Russian Federation	Clinical Research Site in	Kazan
Russian Federation	Clinical Investigative Site	St.Petersburg
Spain	Clinical Investigative Site	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Mast Therapeutics, Inc.

Countries where clinical trial is conducted

Argentina,  Mexico,  Peru,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate
Secondary	Progression Free Survival
Secondary	Overall Survival
Secondary	Duration of Response