NCT00193245已完成2 期
A Randomized Trial of Oral Topotecan Versus Docetaxel in Second-Line Treatment of 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
- 80
- 试验地点
- 2
- 主要终点
- Overall response rate
研究概览
简要总结
In this trial we will evaluate and compare the efficacy and toxicity of oral topotecan with intravenous docetaxel in the second-line treatment of patients with non-small cell lung cancer.
详细描述
Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:
- Topotecan
- Docetaxel
For ever 2 patients treated, 1 will receive treatment A (Topotecan) and 1 will receive treatment B (Docetaxel). The study is not blinded so both the patient and the doctor will know which treatment has been assigned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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:
- •Relapsed or Progressive Disease
- •Stage IIIB (not candidate for combined modality) or IV
- •No more than one prior chemotherapy regimen
- •Able to perform activities of daily living without assistance
- •Measurable disease outside of radiation port
- •Adequate bone marrow, liver and kidney function
- •Must understand study and sign informed consent prior to enrollment
排除标准
- •You cannot participate in this study if any of the following apply to you:
- •Prior treatment with Topotecan or Docetaxel
- •Uncontrolled brain metastases
- •Moderate peripheral neuropathy
- •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
- Time to Progression
- Overall survival
- Overall toxicity
研究者
研究点 (2)
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