NCT00434369Unknown2 期
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
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 31
- 试验地点
- 7
- 主要终点
- Overall Response Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
- •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.
排除标准
- •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.
结局指标
主要结局
Overall Response Rate
次要结局
- Progression Free Survival
- Overall Survival
- Duration of Response
研究者
研究点 (7)
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