Carboplatin and Paclitaxel Plus ASA404 as First Line Chemotherapy for Extensive-Stage Small-Cell Lung Cancer (ES-SCLC): A Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 12
- 主要终点
- Progression-free survival rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Dimethylxanthenone acetic acid may stop the growth of small cell lung cancer by blocking blood flow to the tumor. Giving paclitaxel and carboplatin together with dimethylxanthenone acetic acid may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving paclitaxel and carboplatin together with dimethylxanthenone acetic acid and to see how well they work in treating patients with extensive-stage small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- To assess the 24-week (6 months) progression-free survival of patients with extensive stage small cell lung cancer treated with paclitaxel, carboplatin, and dimethylxanthenone acetic acid.
Secondary
- To assess efficacy and safety of this regimen in these patients.
- To evaluate predictive molecular markers for gene expression analyses, serum proteomics, and pharmacogenomics. (exploratory)
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
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
Paclitaxel, Carboplatin, ASA404
干预措施: paclitaxel (Drug)
Paclitaxel, Carboplatin, ASA404
干预措施: carboplatin (Drug)
Paclitaxel, Carboplatin, ASA404
干预措施: vadimezan (Drug)
结局指标
主要结局
Progression-free survival rate
时间窗: at 24 weeks (6 months)
The status of progression free survival at 24 weeks (+/- 2 weeks) from trial registration will be assessed. A PFS event is defined as (whichever occurs first): * Relapse or progression assessed according to the RECIST 1.1 criteria (Appendix 1) * Death of any cause.
次要结局
- Adverse events by NCI CTCAE v3.0(until 30 days after trial therapy end)
- Best objective response OR complete or partial response according to RECIST 1.1(whilst receiving the trial therapy)
- Time to progression(Defined as the time from registration until documented Small-cell Lung Cancer (SCLC) progression or death as a result of SCLC.)
- Overall survival(Time from registration until death as a result of any cause.)
- One-year survival rate(at 1 year)
研究者
研究点 (12)
标识符
- NCT 编号
- NCT01057342
- 其他研究编号
- SAKK 15/08, SWS-SAKK-15-08, EUDRACT-2009-016960-34, EU-21001, NOVARTIS-CASA404ACCH01T
日期
- 首次提交
- (16年前)
- 首次发布
- (16年前)
- 主要完成日期
- 研究完成日期
- 最近核实
- 最近更新
- (13年前)
监管与共享
- FDA 监管药物
- 否
- 是否有结果
- 否