NCT00193401已完成2 期
Phase II Trial of Weekly Topotecan in the First-line Treatment of Elderly Patients With 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
- 40
- 主要终点
- Overall response rate
研究概览
简要总结
In this phase II trial, we will evaluate the weekly schedule of topotecan in the first-line treatment of elderly and/or poor performance status patients with extensive stage small cell lung cancer. Patients eligible for this trial will be those considered poor candidates for standard combination chemotherapy or other investigational regimens
详细描述
Upon determination of eligibility, all patients will be receive:
- Topotecan
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 small cell lung cancer, extensive stage disease
- •Age > 65 years
- •No previous chemotherapy or radiation therapy.
- •Measurable or evaluable disease.
- •Adequate bone marrow, liver and kidney function.
- •Must be > 4 weeks from previous major surgery
- •Must give written informed consent prior to study entry.
排除标准
- •You cannot participate in this study if any of the following apply to you:
- •Meningeal involvement
- •Serious active infections
- •Serious underlying medical conditions
- •Other active neoplasms
- •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
- Median survival
- 1 year and 2 year survival
- Overall toxicity
研究者
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