Phase II Trial of Patupilone in Patients With Brain Metastases From Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 9
- 主要终点
- Central Nervous System (CNS) Progression-free Survival(PFS)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as epothilone B, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well epothilone B works in treating patients with CNS metastases from breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the 3-month CNS-progression free survival of patients with CNS metastases secondary to breast cancer treated with epothilone B.
Secondary
- Determine the toxicity of this drug in these patients.
- Determine the CNS response rate and duration of CNS response in patients treated with this drug.
- Determine the systemic disease response rate and duration of systemic response in patients treated with this drug.
- Determine the overall survival of patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Central Nervous System (CNS) Progression-free Survival(PFS)
时间窗: 3 months after treatment
The number of patients that are documented to have progression free survival at 3 months after treatment. Progression free is define as \<25% increase in tumor area. PFS will be measured from the date of entry into the trial to the date of documented progression of brain metastases or death.
次要结局
- Overall Survival(48 months from start of study)
- Toxicity as Measured by NCI CTCAE v3.0(3 months after treatment)
- CNS Response Rate, for Measurable Disease Will be Assessed by the Modified McDonald Criteria(3 months after treatment)
- Systemic Disease Response Rate for Measurable Disease Will be Assessed by the Modified McDonald Criteria(3 months after treatment)
研究者
David Peereboom, MD
Principal Investigator
Case Comprehensive Cancer Center