Phase II Trial of Sorafenib in Conjunction With Chemotherapy and as Maintenance Therapy in Extensive-Stage Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 11
- 主要终点
- Progression-free Survival(PFS)
研究概览
简要总结
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving sorafenib together with cisplatin and etoposide works in treating patients with extensive-stage small cell lung cancer.
详细描述
OBJECTIVES:
- To evaluate the 1-year progression-free survival of patients with extensive-stage small cell lung cancer treated with sorafenib tosylate in combination with cisplatin and etoposide.
- To evaluate the 1-year overall survival and response rate in these patients.
- To evaluate the safety of these drugs in these patients.
OUTLINE: This is a multicenter study.
Patients receive cisplatin IV over 30-60 minutes on day 1 and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral sorafenib tosylate twice daily beginning on day 1 of course 1 and continuing for up to 1 year in the absence of disease progression or unacceptable toxicity.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sorafenib, Cisplatin, and Etoposide
干预措施: cisplatin (Drug)
Sorafenib, Cisplatin, and Etoposide
干预措施: etoposide (Drug)
Sorafenib, Cisplatin, and Etoposide
干预措施: sorafenib tosylate (Drug)
结局指标
主要结局
Progression-free Survival(PFS)
时间窗: 1-year
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.
次要结局
- Response Rate(reevaluated for response every 8 weeks)
- Median Overall Survival(1-year)
- Safety(Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity.)
研究者
Afshin Dowlati, MD
Principal Investigator
Case Comprehensive Cancer Center