NCT00294190已完成2 期
A Phase II Study Of Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 13
- 主要终点
- Overall response rate
研究概览
简要总结
This proposed phase II trial will investigate weekly topotecan at a higher dose than was used in the previous trials in an attempt to achieve improved response rates and disease control without added toxicity. To help ameliorate the fatigue, planned rest weeks will be incorporated into the schedule. This trial will be the first clinical trial to evaluate a higher dose of weekly topotecan in the treatment of extensive-stage SCLC.
详细描述
All patients will receive weekly topotecan.
Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break. Cycles are repeated every 8 weeks, for 3 cycles. Restaging studies will be performed every cycle (or 8 weeks.)
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
- •Extensive small cell lung cancer with progression after one previous chemotherapy or chemotherapy/radiation therapy regimen
- •Measurable or evaluable disease
- •Able to perform activities of daily living with minimal assistance
- •Adequate bone marrow, liver and kidney function
- •May have received no more than 3 previous courses of radiation therapy
- •Give written informed consent prior to study entry
排除标准
- •Patients with limited stage disease
- •History of a prior malignancy within three years
- •Female patients who are pregnant or are breast feeding
- •Significant history of uncontrolled cardiac disease
- •Myocardial infarction or stroke within six months
- •Symptomatic peripheral vascular disease
- •CNS involvement
- •Serious active infection or underlying medical condition
研究组 & 干预措施
Topotecan
Experimental
干预措施: Topotecan (Drug)
结局指标
主要结局
Overall response rate
时间窗: 18 months
次要结局
- overall toxicity(18 months)
- time to progression(18 months)
- duration of response(18 months)
- overall survival(18 months)
研究者
研究点 (13)
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