Phase 2 Study of Weekly Topotecan With Docetaxel for Recurrent Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel
研究概览
简要总结
The purposes of this study are:
- To determine the overall response rate of patients treated with at least 2 cycles of this regimen.
- To determine the feasibility and toxicity of the combination of topotecan and docetaxel.
详细描述
The main objective of this study was to determine the overall response rate of patients treated with at least 2 cycles of topotecan and docetaxel. The secondary objectives were to determine the feasibility and toxicities of this combination. The final secondary objective is overall survival for patients that received 2 or more cycles.
Methods: Eligible pts with recurrent small cell lung cancer had to be at least 3 months from initial treatment. Pts received Docetaxel 30 mg/m2 IV followed by Topotecan 3 mg/m2 IV Days 1 and 8 of a 21 day cycle. Disease assessment was done every 2 cycles. Toxicity was measured each cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Recurred greater than 90 days after initial treatment
- •At least 1 measurable lesion
- •Only 1 prior chemotherapy
- •Must be over 18 years of age
- •ECOG performance status of 0 - 2
- •Adequate hematologic, renal, and hepatic function
排除标准
- •No prior use of topotecan, docetaxel, or irinotecan
- •No symptomatic brain metastases
- •History of cardiac arrhythmias, congestive heart failure, stroke, or embolic events
- •No prior investigational agents within 1 month prior
- •Lung cancer of mixed histology
- •Known uncontrolled seizure disorders
研究组 & 干预措施
Arm A
Weekly intravenous topotecan with intravenous docetaxel
干预措施: Intravenous Topotecan (Drug)
Arm A
Weekly intravenous topotecan with intravenous docetaxel
干预措施: Intravenous Docetaxel (Drug)
结局指标
主要结局
To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel
时间窗: 3 years
To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel
次要结局
未报告次要终点