PER-118-06已完成未知
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
ADVENTRIX PHARMACEUTICALS U.S.A,0 个研究点目标入组 0 人开始时间: 2007年5月29日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •1. Signed informed consent.
- •2. Women with a histologically / cytologically proven diagnosis of breast adenocarcinoma.
- •3. Measurable disease. At least one non-bone lesion measurable in a one-dimensional form, with a diameter> 10 mm using computed helical computed tomography or magnetic resonance imaging according to the RECIST criteria.
- •4. Patients who have failed with both previous chemotherapy regimens with anthracycline and taxane derivatives.
排除标准
- •1. Positive tumor Her2 / neu 2+ or 3+.
- •2. Pregnancy or lactation.
- •3. Systemic cytotoxic anticancer therapy, within ≤ 4 weeks of enrollment or 6 weeks if systemic therapy contains a nitrosourea or mitomycin.
- •4. Previous chemotherapy with 5-FU- and / or palliative chemotherapy based on capecitabine.
- •5. Extensive prior radiation therapy that affects more than 30% of the bone marrow reserves, or bone marrow / stem cell transplant.
- •6. Participation in clinical studies of non-approved experimental substances or procedures within ≤ 4 weeks of study enrollment.
- •7. History of another malignancy, unless the patient is cured and has been free of disease for ≥ 2 years.
- •8. Previous unforeseen reaction to fluoropyrimidines with or without documented deficiency of dihydropyrimidine dehydrogenase, or a history of hypersensitivity to 5-FU.
- •9. Psychological, family, sociological or geographical states that do not allow compliance with the protocol of the study and / or the study.
- •10. Significant heart disease, including symptomatic ventricular arrhythmia, congestive heart failure, myocardial infarction within 12 months prior to enrollment.
- •11. Concomitant treatment with any experimental drug or anticancer drug.
研究者
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