NCT00193336已完成2 期
Phase II Trial of Single Agent ZD1839 (Iressa) in Poor Performance Status Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Overall response rate
研究概览
简要总结
Because of the demonstrated single agent activity and excellent tolerability in patients with refractory non-small cell lung cancer, ZD1839 may be of benefit in the first-line treatment of patients with advanced non-small cell lung cancer who have poor performance status. In this phase II trial, we will investigate the single agent activity of first-line ZD1839 in patients with advanced non-small cell lung cancer with poor performance status
详细描述
Upon determination of eligibility, patients will be receive:
- ZD1839
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
- •To be included in this study, you must meet the following criteria:
- •Biopsy proven non-small cell lung cancer
- •Recurrent non-small cell lung cancer after previous surgery or radiation
- •Advanced disease (stage IIIb or IV)
- •No previous chemotherapy or biological therapy
- •Require significant assistance with activities of daily living
- •Measurable disease
- •Adequate bone marrow, liver and kidney function
- •Give written informed consent
排除标准
- •You cannot participate in this study if any of the following apply to you:
- •Brain metastasis
- •Meningeal metastasis
- •Other uncontrolled malignancies
- •Women pregnant or lactating
- •No measurable disease outside previous radiation therapy field
- •Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
结局指标
主要结局
Overall response rate
次要结局
- Quality of life
- Overall toxicity
研究者
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