Phase II Study of Second-Line Bendamustine in Relapsed or Refractory Small Cell Lung Cancer (SCLC).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Time to Progression
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well bendamustine works as second- or third-line therapy in treating patients with relapsed or refractory small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- To determine the time to progression in patients with relapsed or refractory small cell lung cancer treated with second- or third-line bendamustine.
Secondary
- To determine the toxicity of this drug in these patients.
- To determine the response rate, progression-free survival, and overall survival of patients treated with this drug.
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
Bendamustine
干预措施: bendamustine hydrochloride (Drug)
结局指标
主要结局
Time to Progression
时间窗: On-study to date of progression, measured following cycle 2, 4, and 6 of a 21-day cycle for 6 cycles, (during 126 days)
Estimated probable duration from on-study date to date of disease progression, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as \>=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.
次要结局
- Number of Patients With Each Worst-grade Toxicity(Day 1 of each 21-day cycle for 6 cycles and at 30 days after end of treatment, at 156 days)
- Best Response(On-treatment date to date of disease progression, following cycle 2, 4, and 6 of a 21-day cycle for 6 cycles, (assessed up to 126 days))
- Progression-free Survival(On-study date to lesser of date of progression or date of death from any cause ,measured following cycle 2, 4, 6 of a 21-day cycle for 6 cycles, (assessed up to 126 days))
- Overall Survival(On study to date of death from any cause or last date known alive, measured every 6-8 weeks from the end of treatment, up to 31 months)
研究者
Leora Horn, MD
Assistant Professor of Medicine; Assistant Director, Educator Development Program; Clinical Director, Thoracic Oncology Program; Medical Oncologist
Vanderbilt-Ingram Cancer Center