NCT00450866已完成2 期
Phase II Trial of Patupilone in Patients With Brain Metastases From Breast Cancer
David Peereboom, MD5 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2007年1月1日最近更新:
适应症
干预措施
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
- 5
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed carcinoma of the breast
- •CNS metastases (i.e., brain parenchymal lesions and/or leptomeningeal disease), meeting 1 of the following criteria:
- •Recurrent or progressive CNS metastases after whole brain radiotherapy
- •If only evaluable site of CNS progression has been previously treated with stereotactic radiosurgery, radiation necrosis must be excluded by radiographic (e.g., positron emission tomography scan or magnetic resonance spectroscopy) or histologic assessment
- •Newly diagnosed, untreated, asymptomatic brain or leptomeningeal metastases
- •Patient must be neurologically stable, as demonstrated by a stable dose of steroids and anticonvulsants for ≥ 1 week prior to obtaining baseline gadolinium-enhanced MRI of the brain and/or ≥ 1 week prior to beginning study treatment
- •No CNS complications requiring urgent neurosurgical intervention (e.g., resection or shunt placement)
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Male or female
- •Menopausal status not specified
- •Karnofsky performance status 60-100%
- •Life expectancy ≥ 3 months
- •Absolute neutrophil count > 1,500/mm^3
- •Hemoglobin > 9.0 g/dL
- •Platelet count > 100,000/mm^3 (red blood cell transfusion and repeat evaluation allowed)
- •Bilirubin < 1.5 times upper limit of normal (ULN)
- •AST and ALT < 2.5 times ULN
- •Alkaline phosphatase < 2.5 times ULN
- •Creatinine < 1.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after completion of study therapy
- •No known hypersensitivity to epothilones
- •No peripheral neuropathy > grade 1
- •No unresolved diarrhea within the past 7 days
- •Grade 0 diarrhea required at study entry
- •No concurrent serious medical illness (e.g., HIV positivity or active hepatitis B or C)
- •No severe cardiac insufficiency (e.g., New York Heart Association class III-IV heart disease) with uncontrolled and/or unstable cardiac or coronary artery disease
- •No active or suspected acute or chronic uncontrolled infection, including abscess or fistulae
- •No other malignancy within the past 3 years except curatively treated nonmelanoma skin cancer, prostate cancer, or carcinoma in situ of the cervix
- •No history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits
- •No contraindications to MRI, including any of the following:
- •Pacemaker
- •Ferromagnetic implants
- •Claustrophobia
- •Extreme obesity
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •More than 2 weeks since prior noncytotoxic drugs (e.g., small molecule-targeted drugs) and recovered
- •More than 3 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
- •More than 3 weeks since prior intracranial surgery and recovered
- •More than 4 weeks since prior radiotherapy and recovered
- •More than 4 weeks since prior major surgery
- •More than 28 days since prior investigational compounds or drugs
- •No prior epothilones
- •No concurrent known diarrheagenic agents
- •No other concurrent anticancer agents, including investigational agents, biological agents, or chemotherapy
- •No other concurrent experimental therapies
- 另有 7 项未显示
排除标准
- 未提供
研究组 & 干预措施
Epothilone B
Experimental
干预措施: epothilone B (Biological)
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
- CNS Response Rate, for Measurable Disease Will be Assessed by the Modified McDonald Criteria(3 months after treatment)
- Overall Survival(48 months from start of study)
- Toxicity as Measured by NCI CTCAE v3.0(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
研究点 (5)
Loading locations...
相似试验
已完成
2 期
BMS-247550 in Treating Women With Metastatic Breast CancerBreast CancerNCT00020904Memorial Sloan Kettering Cancer Center
已完成
2 期
BMS-247550 in Treating Patients With Recurrent or Metastatic Colorectal CancerColorectal CancerNCT00022477University of Chicago24
已完成
2 期
Pemetrexed, Carboplatin, and Bevacizumab as First-Line Therapy in Treating Older Patients With Stage IIIB or Stage IV Non-Small Cell Lung CancerLung CancerNCT00798603Alliance for Clinical Trials in Oncology65
已完成
2 期
BMS-247550 in Treating Patients With Metastatic Stomach Cancer Previously Treated With ChemotherapyGastric CancerEsophageal CancerNCT00017043Bristol-Myers Squibb
已完成
2 期
BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone TherapyProstate CancerNCT00016393SWOG Cancer Research Network