NCT00465673终止2 期
A Phase II Study of Liposomal Doxorubicin (Lipo-Dox) in Patients With Brain Metastasis From Breast Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2005年9月最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Determine the brain response rate of Lipo-Dox in breast cancer patients with brain metastasis
研究概览
简要总结
Primary objective:
To determine the brain response rate of Lipo-Dox in breast cancer patients with brain metastasis
Secondary objectives:
- To determine the overall objective response rate (ORR)
- To determine the progression free survival, and duration of objective response
- To evaluate the overall survival (OS)
- To assess the safety profiles
详细描述
This is an open-label, non-comparative phase II clinical trial. Approximately thirty-three patients will be enrolled in order to obtain twenty-nine evaluable subjects who received two cycles of study treatment in Simon's 2-stage optimal design.
Duration of subject involvement: Study treatment should be administered up to disease progression, intolerable toxicity, or consent withdrawal.
Recruitment period: 10 months
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically proved breast cancer
- •Relapse/recurrent brain metastasis progression after brain radiotherapy
- •Presence of brain measurable disease which is defined as at least one brain lesion that can be measured in at least 1 dimension as ³ 20 mm with magnetic resonance image (MRI)
- •Prior chemotherapy or hormone therapy for metastatic breast cancer is allowed
- •Performance status of ECOG 0, 1, 2
- •With normal left ventricular ejection fraction and normal ventricular contractility
- •Age 21 years or older
- •Life expectancy equal or longer than 3 months
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Prior anthracycline-containing chemotherapy with cumulative dose exceed 400mg/m2 doxorubicin or 750 mg/m2 Epirubicin
- •Surgery , radiotherapy, hormonal therapy or chemotherapy within 4 weeks prior to entering the study
- •Prior liposomal doxorubicin treatment
- •Concurrent chemotherapy, radiotherapy, hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period
- •Other malignancy with exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to entering the study
- •Brain metastases defined as meninges metastases
- •Presence of serious concomitant illness which might be aggravated by study medication:
- •Uncontrolled infection (active serious infections that are not controlled by antibiotics)
- •Active cardiac disease e.g. decompensate myocardial infarction within the 6-month period preceding entry into the study.
- •History of ventricular arrhythmia or congestive heart failure.
- •Presence of abnormal left ventricular ejection fraction
- •Hematopoietic function as defined below:
- •Hemoglobin<10g/dl
- •ANC< 1,500/uL
- •Platelets<100,000/uL
- •Organ function as defined below:
- •Total bilirubin >1.5 × ULN
- •ALT / AST>3 × ULN (>5.0 x ULN if hepatic metastasis)
- •Creatinine >1.5 × ULN
- •Mental status is not fit for clinical trial
- •Pregnant or breast feeding women, or women of child-bearing potential unless using a reliable and appropriate contraceptive method
结局指标
主要结局
Determine the brain response rate of Lipo-Dox in breast cancer patients with brain metastasis
时间窗: 3 years
次要结局
- To determine the overall objective response rate(3 years)
- To determine the progression free survival, and duration of objective response(3 years)
- To evaluate the overall survival(3 years)
- To assess the safety profiles(3 years)
研究者
研究点 (2)
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