NCT00128700已完成1 期
Phase I/II Study on Concomitant and Adjuvant Temozolomide and Radiotherapy With or Without PTK787/ZK222584 in Newly Diagnosed GBM
European Organisation for Research and Treatment of Cancer - EORTC10 个研究点 分布在 5 个国家目标入组 20 人开始时间: 2005年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 10
- 主要终点
- Dose-limiting toxicity and maximum tolerated dose of vatalanib as determined by CTCAE v3.0 during phase I
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Vatalanib may stop the growth of tumor cells by blocking blood flow to the tumor. Giving temozolomide and radiation therapy together with vatalanib may kill more tumor cells.
PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of vatalanib when given together with temozolomide and radiation therapy and to see how well they work in treating patients with newly diagnosed glioblastoma multiforme.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and recommended phase II dose of vatalanib when given in combination with temozolomide and radiotherapy in patients with newly diagnosed glioblastoma multiforme. (Phase I)
- Determine the safety and tolerability of this regimen in these patients. (Phase I)
- Determine the 6-month progression-free survival of patients treated with chemoradiotherapy comprising temozolomide and radiotherapy with or without vatalanib followed by adjuvant therapy comprising temozolomide and vatalanib or temozolomide alone with or without maintenance therapy comprising vatalanib alone. (Phase II)
Secondary
- Determine 12-month overall survival of patients treated with these regimens. (Phase II)
- Determine the toxicity profile of these regimens in these patients. (Phase II)
- Correlate expression of angiogenesis and hypoxia markers and MGMT methylation status with clinical outcome in patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed glioblastoma multiforme
- •Newly diagnosed disease
- •Deemed to be amenable to concurrent and adjuvant temozolomide treatment by the principal investigator
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin < 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase < 2.5 times ULN
- •ALT and AST < 2.5 times ULN
- •Creatinine ≤ 1.7 mg/dL
- •Cardiovascular
- •Cardiac function clinically normal
- •12-lead ECG normal
- •No ischemic heart disease within the past 6 months
- •No uncontrolled cardiac arrhythmia
- •No uncontrolled hypertension
- •No history of stroke
- •No history of congenital long QT syndrome
- •QTc interval ≤ 450 msec for males or ≤ 470 msec for females by 12-lead ECG
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other malignancy except adequately treated basal cell or squamous cell skin cancer or cone biopsied carcinoma in situ of the cervix
- •No active uncontrolled infection
- •No other unstable systemic disease
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance or follow-up schedule
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior anti-vascular endothelial growth factor therapy
- •Chemotherapy
- •No prior chemotherapy
- •Endocrine therapy
- •Concurrent corticosteroids allowed provided the patient is on stable or decreasing doses for ≥ 2 weeks before study entry
- •Radiotherapy
- •No prior radiotherapy
- •More than 8 days, but < 6 weeks, since prior surgery or biopsy
- •No prior randomization on this study
- •No concurrent warfarin, warfarin-derived drugs, or similar anticoagulants
- •No other concurrent anticancer therapy
- •No other concurrent investigational agents
- •No concurrent enzyme inducing antiepileptic drugs, including any of the following:
- •Carbamazepine
- •Fosphenytoin
- •Oxcarbazepine
- •Phenobarbital
- 另有 3 项未显示
排除标准
- 未提供
结局指标
主要结局
Dose-limiting toxicity and maximum tolerated dose of vatalanib as determined by CTCAE v3.0 during phase I
Progression-free survival at 6 months during phase II
次要结局
- Severe toxic events as assessed by CTCAE v3.0 at weeks 3 and 6 (concomitant treatment), weeks 2 and 4 after radiotherapy, before each course of adjuvant treatment, monthly during maintenance treatment, and every 3 months during follow-up in phase II
- Overall survival at 1 year during phase II
- Correlation of angiogenesis and hypoxia markers expression and O-6-methylguanine DNA methyltransferase (MGMT) methylation status with clinical outcome during phase II
研究者
研究点 (10)
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