Phase II Study of Camtobell Inj.(Belotecan) in Combination With Cisplatin in Patients With Previously Untreated, Extensive-stage Small-cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Response rate as assessed by RECIST criteria
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Belotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving belotecan together with cisplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well belotecan works when given together with cisplatin in treating patients with previously untreated extensive stage small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- To assess the antitumor efficacy, in terms of objective response rate, of belotecan hydrochloride and cisplatin in patients with previously untreated extensive-stage small cell lung cancer.
Secondary
- To assess additional evidence of antitumor activity as measured by overall and progression-free survival of these patients.
- To determine the safety and tolerability of this drug combination in these patients.
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 75 Years（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
belotecan and Cisplatin
belotecan 0.5 mg/m2 and Cisplatin 60mg/m2
干预措施: belotecan hydrochloride (Drug)
belotecan and Cisplatin
belotecan 0.5 mg/m2 and Cisplatin 60mg/m2
干预措施: cisplatin (Drug)
结局指标
主要结局
Response rate as assessed by RECIST criteria
时间窗: 21days(1cycle)
Overall survival
时间窗: 21days(1cycle)
Progression-free survival
时间窗: 21days(1cycle)
Hematologic and non-hematologic toxicity as assessed by NCI CTCAE v3.0
时间窗: 21days(1cycle)
次要结局
未报告次要终点