An Open-label Phase II Study of Weekly Intravenous Hycamtin and Carboplatin as First-line Treatment of Chemonaive Subjects With Extensive Disease Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Overall Response Rate, as Determined by Radiologic Evaluation (Utilizing the World Health Organization [WHO] Criteria), Calculated as the Number of Participants With the Indicated Response
研究概览
简要总结
This study was designed to find the safest and most effective dose of a combination of two chemotherapy drugs, Hycamtin® (topotecan) and Paraplatin® (carboplatin), in people with extensive disease small cell lung cancer.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Single arm, open label
干预措施: topotecan (Drug)
Single arm, open label
干预措施: carboplatin (Drug)
结局指标
主要结局
Overall Response Rate, as Determined by Radiologic Evaluation (Utilizing the World Health Organization [WHO] Criteria), Calculated as the Number of Participants With the Indicated Response
时间窗: Baseline until up to Day 169
The categories of tumor response were: complete response (complete disappearance of all known lesions determined by 2 measurements not less than 4 weeks apart), partial response (\>50% decrease in measurable lesions for at least 4 weeks with no appearance of new lesions), stable disease (no change in tumor size for at least 8 weeks), progressive disease (\>25% increase in measurements of lesions or appearance of new lesions), and not evaluable. The overall response rate was determined using a scan performed within the first 30 days of the first response.
次要结局
- Overall Survival, Calculated as the Number of Subjects Who Died From the Start of Treatment Until Follow-up(Week 1 up to maximum of Day 519)
- Grade 1 (Mild) Hematological Toxicities(Week 1 through Endpoint (variable based on disease progression or toxicity))
- Time to Response(From start of treatment to evidence of partial or complete response)
- Response Duration(From time of partial or complete response to disease progression/death)
- Time to Progression(From start of treatment to disease progression/death)
- Grade 4 (Life-threatening or Disabling) Hematological Toxicities(Week 1 through Endpoint (variable based on disease progression or toxicity)
- Grade 2 (Moderate) Hematological Toxicities(Week 1 through Endpoint (variable based on disease progression or toxicity)
- Grade 3 (Severe) Hematological Toxicities(Week 1 through Endpoint (variable based on disease progression or toxicity)