5-Fluorouracil Combined With CoFactor (5-10 Methylenetetrahydrofolate) in Treating Advanced Breast Cancer Patients
This trial is active, not recruiting.
|Sponsor||Mast Therapeutics, Inc.|
|Start date||February 2006|
|Trial size||31 participants|
|Trial identifier||NCT00434369, 510-08|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Buenos Aires, Argentina||Clinical Research Site in||no longer recruiting|
|Acapulco, Mexico||Clinical Investigative Site||no longer recruiting|
|Lima, Peru||Clinical Investigative Site||no longer recruiting|
|Kazan, Russian Federation||Clinical Research Site in||no longer recruiting|
|St.Petersburg, Russian Federation||Clinical Investigative Site||no longer recruiting|
|Valencia, Spain||Clinical Investigative Site||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Overall Response Rate
Progression Free Survival
Duration of Response
Female participants at least 18 years old.
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.
|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|
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