NCT00830245终止2 期
A Study to Assess the Efficacy of Erlotinib for Leptomeningeal Carcinomatosis in EGFR Mutation Positive Non-small Cell Lung Cancer
Clinical Research Center for Solid Tumor, Korea1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
To assess the efficacy and safety of erlotinib for non-small cell lung cancer patients with leptomeningeal carcinomatosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologically or pathologically proven non-small cell lung cancer (NSCLC)
- •Leptomeningeal carcinomatosis confirmed by CSF cytology
- •A patients with EGFR mutation (including exon 19 deletion, L858R)
- •ECOG performance status 0-3
- •Expected life time more than at least 4 weeks
- •A patients who signed the informed consent prior to the participation in the study
- •Chemotherapy-naïve patient is eligible
- •Previous EGFR TKI is allowed if this drug was not specifically used for CNS metastases
排除标准
- •A pregnant or lactating patient
- •A patient of childbearing potential without being tested for pregnancy at baseline or with a positive test. (A postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
- •A man or woman of childbearing potential without the willingness to use a contraceptive measures during the study
- •A patient with history of another malignant disease within past 3 years, except curatively treated basal cell carcinoma of the skin, cervical carcinoma in situ, and early gastric cancer
- •A patient with active interstitial lung disease, except simple lymphangitic lung metastasis
- •A patient with history of allergic reaction to gefitinib or erlotinib
- •The following laboratory test results:
- •Number of absolute neutrophils counts (ANC) < 1.0ⅹ109/L
- •Number of platelets < 50 ⅹ109/L
- •AST, ALT > 2.5 ⅹupper limit of normal
- •Total bilirubin > 1.5 ⅹupper limit of normal
- •Serum creatinine > 1.5 ⅹupper limit of normal
- •A patient with serious disease as followings
- •Uncontrolled cardiac arrhythmia
- •History of myocardial infarction within 6 months prior to the initiation of study
- •Neurological or psychiatric disorder including dementia or uncontrolled seizure
- •A patient who refused to sign the informed consent
研究组 & 干预措施
Erlotinib
Experimental
Erlotinib 150mg/day (if no negative conversion --> increment to 250mg/day)
干预措施: Erlotinib (Drug)
结局指标
主要结局
Overall survival
时间窗: 1 year
次要结局
- Cytology negative conversion rate(1 month, 2 months, 3 months, 4 months)
- Neurologic symptom improvement(1 month, 2 months, 3 months, 4 months)
- Response rate (extra-cranial disease)(2 months, 4 months)
- Response rate (brain)(2 months, 4 months)
- Quality of life(1 month, 2 months, 3 months, 4 months)
- Toxicities(1 month, 2 months, 3 months, 4 months)
- Prognostic factors(N-A)
研究者
研究点 (1)
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