NCT00424060已完成2 期
Phase II Study of ZK 219477 in Patients With Recurrent Glioblastoma
European Organisation for Research and Treatment of Cancer - EORTC2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2006年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Treatment success (complete or partial response or a progression-free survival at 6 months)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as epothilone ZK-219477, 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 ZK-219477 works in treating patients with recurrent glioblastoma.
详细描述
OBJECTIVES:
Primary
- Assess the therapeutic activity of epothilone ZK-219477 in patients with recurrent glioblastoma.
Secondary
- Determine the safety profile, mechanism of action, and pharmacokinetics of this drug in these patients.
- Gather information about the biological characteristics of the patients' tumor that may provide information on response or resistance to this drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 confirmed glioblastoma
- •Presence of oligodendroglial elements allowed provided they make up < 25% of tumor
- •Measurable disease, defined as ≥ 1 bidimensionally measurable target lesion with a largest diameter of ≥ 2 cm by MRI within the past 2 weeks
- •Recurrent disease
- •Documented by MRI after failing prior therapy (usually standard radiotherapy with concurrent and maintenance temozolomide)
- •Subsequent histologic confirmation of recurrence required for patients who received prior high-dose radiotherapy (> 65 Gy), stereotactic radiosurgery, or internal radiotherapy
- •Multifocal disease that is not amenable to radiotherapy allowed provided the patient received no more than 1 line of prior chemotherapy
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •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
- •Clinically normal cardiac function
- •No ischemic heart disease within the past 12 months
- •Stable ischemic heart disease (e.g., treated angina that is stable under appropriate therapy) allowed
- •No New York Heart Association class III or IV cardiac insufficiency
- •No unstable angina
- •No arrhythmia
- •No psychological, familial, sociological, or geographical factors that would preclude study compliance
- •No other malignancy except cone-biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile female patients must use effective contraception during and for 3 months after completion of study treatment
- •Fertile male patients must use effective contraception during and for 6 months after completion of study treatment
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- •More than 3 months since prior radiotherapy to the brain
- •More than 3 months since prior surgery for recurrent primary brain tumor unless 1 of the following criteria are met:
- •Measurable residual disease documented by immediate (within 72 hours) postoperative imaging
- •Evidence of a progressive and measurable target lesion found at postoperative follow-up
- •Presence of a second measurable target lesion outside the surgical area
- •Prior adjuvant temozolomide as first-line therapy allowed
- •No prior chemotherapy for recurrent glioblastoma
- •One prior chemotherapy regimen given as adjuvant therapy allowed
- •Concurrent corticosteroids allowed provided dose is stable or decreasing for ≥ 1 week
- •No concurrent phenytoin, carbamazepine, or phenobarbital
- •No concurrent Hypericum perforatum (St. John's wort)
- •No concurrent enzyme-inducing antiepileptic drugs (EIAEDs)
- •Patients on EIAEDs should have been switched to non-EIAEDs with a wash-out period of ≥ 1 month
- •No other concurrent anticancer agents (except alternative or homeopathic medicine)
- •No other concurrent investigational treatment
排除标准
- 未提供
结局指标
主要结局
Treatment success (complete or partial response or a progression-free survival at 6 months)
次要结局
- Objective response
- Duration of response
- Toxicity
- Progression-free survival at 6 months
- Overall survival at 6 and 12 months
研究者
研究点 (2)
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