NCT00086879已完成2 期
Randomized Phase II of TARCEVA™ (Erlotinib) Versus Temozolomide Or BCNU in Patients With Recurrent Glioblastoma Multiforme
European Organisation for Research and Treatment of Cancer - EORTC10 个研究点 分布在 5 个国家目标入组 110 人开始时间: 2004年5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
- 110
- 试验地点
- 10
- 主要终点
- Progression-free survival at 6 months
研究概览
简要总结
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as temozolomide and carmustine, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether erlotinib is more effective than temozolomide or carmustine in treating recurrent glioblastoma multiforme.
PURPOSE: This randomized phase II trial is studying erlotinib to see how well it works compared to temozolomide or carmustine in treating patients with recurrent glioblastoma multiforme.
详细描述
OBJECTIVES:
Primary
- Compare the therapeutic activity of erlotinib vs temozolomide or carmustine in patients with recurrent glioblastoma multiforme.
- Compare 6-month progression-free survival in patients treated with these drugs.
Secondary
- Compare the safety of these drugs in these patients.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed glioblastoma multiforme
- •Some oligodendroglial elements allowed provided they make up < 25% of the tumor
- •Recurrent disease documented by MRI after prior radiotherapy
- •At least 1 bidimensionally measurable target lesion ≥ 2 cm by MRI
- •Undergone prior surgery for recurrent primary brain tumor more than 3 months before study entry
- •Must have a clearly limited target lesion ≥ 2 cm OR evidence of progressive and measurable target lesion OR a second measurable target lesion outside the surgical area
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm ^3
- •AST and ALT < 2.5 times upper limit of normal (ULN)
- •Bilirubin < 1.5 times ULN
- •Creatinine < 1.5 times ULN
- •Cardiovascular
- •Clinically normal cardiac function
- •No ischemic heart disease within the past 12 months
- •No New York Heart Association grade III or IV cardiac insufficiency
- •No unstable angina
- •No arryhthmia
- •DLCO > 70% of predicted (for patients randomized to receive erlotinib [arm I] or carmustine [arm II])
- •No history of pulmonary disease that would affect pulmonary function including any of the following:
- •Chronic bronchopneumopathy
- •Pleural effusion
- •Interstitial pnuemonia
- •Pulmonary lymphangitis
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study participation
- •No other malignancy except cone biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer
- •No psychological, familial, sociological, or geographical factors that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior HER-targeted agents
- •No concurrent growth factors for neutrophil count elevation
- •No concurrent epoetin alfa
- •Chemotherapy
- •Prior adjuvant temozolomide allowed
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- •No more than 1 prior adjuvant chemotherapy regimen
- •No prior chemotherapy for recurrent disease
- •Endocrine therapy
- •Must be on a stable or decreasing dose of corticosteroids for at least 2 weeks before study entry
- •Radiotherapy
- •See Disease Characteristics
- •More than 3 months since prior radiotherapy to the brain
- 另有 7 项未显示
排除标准
- 未提供
结局指标
主要结局
Progression-free survival at 6 months
次要结局
- Severe toxic events assessed by CTCAE v3.0 at the end of each course
- Response (complete [CR] or partial response [PR]) measured by McDonald's criteria at least 4 weeks after first documented response and every 8 weeks until disease progression or until start of another treatment
- Progression-free survival at 1 year
- Overall survival at 6 months and 1 year
研究者
研究点 (10)
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