NCT00054496Unknown2 期
Phase II Study Trial Of Tarceva In Patients With Recurrent/Progressive Glioblastoma Multiforme
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
RATIONALE: Erlotinib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have recurrent or progressive glioblastoma multiforme.
详细描述
OBJECTIVES:
- Determine the response rate of patients with recurrent or progressive glioblastoma multiforme treated with erlotinib.
- Determine the progression-free and overall survival of patients treated with this drug.
OUTLINE: Patients receive oral erlotinib daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 73 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 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 multiforme
- •Radiographic evidence of recurrence or progression
- •Biopsies to confirm tumor recurrence allowed if a sufficent percentage of cases are confirmed to be recurrent tumor
- •Previously treated with optimal radiotherapy and at least 1 cytotoxic chemotherapy regimen
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 2 times normal
- •Alkaline phosphatase no greater than 2 times normal
- •ALT no greater than 3 times normal
- •BUN no greater than 1.5 times normal OR
- •Creatinine no greater than 1.5 times normal
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No medical condition that would interfere with oral administration of erlotinib
- •No other medical or psychiatric illness that would preclude study therapy
- •No active infection
- •No other malignancy within the past 3 years except surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent immunotherapy for brain cancer
- •No concurrent biologic therapy for brain cancer
- •Chemotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- •No concurrent chemotherapy for brain cancer
- •Endocrine therapy
- •Concurrent glucocorticosteroids allowed
- •No concurrent hormonal therapy for brain cancer
- •Radiotherapy
- •See Disease Characteristics
- •Not specified
- •No prior epidermal growth factor receptor (EGFR) inhibitor
- •No concurrent EGFR inhibitor
- •No other concurrent antineoplastic therapy
- •No concurrent anti-epileptic agents other than modest- or non-enzyme-inducing drugs such as the following:
- •Gabapentin
- •Lamotrigine
- •Divalproex
- •Felbamate
- •Levetiracetam
- •Tiagabine
- 另有 2 项未显示
排除标准
- 未提供
结局指标
主要结局
Response rate
次要结局
- Overall survival
- Efficacy of erlotinib in inhibiting epidermal growth factor receptor (EGFR) signaling
- Efficacy of tumor EGFR amplification in predicting response to treatment
- Progression-free survival
研究者
研究点 (1)
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