Phase II Trial of Liposome Encapsulated SN38 (LE-SN38) in the Treatment of Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Tumor response measured by number of responses
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as liposomal SN-38, 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 liposomal SN-38 works in treating patients with small cell lung cancer.
详细描述
OBJECTIVES:
- Determine the response rate in patients with small cell lung cancer treated with SN-38 liposome that is dosed according to a UGT1A1-specific genotype.
- Determine the toxicity of this drug in these patients.
- Determine, preliminarily, overall and progression-free survival of patients treated with this drug.
- Determine the quality of life of patients treated with this drug.
- Correlate UGT1A1-specific haplotypes with toxicity of this drug in these patients.
- Correlate UGT1A1-specific haplotypes with outcomes of patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to length of time since prior treatment (previously untreated disease OR chemosensitive disease and ≥ 3 months since prior treatment vs refractory disease OR chemoresistant disease and < 3 months since prior treatment).
Patients receive SN-38 liposome IV over 90 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response or patients with stable disease (SD) who were previously treated before study enrollment receive up to 4 additional courses of treatment. Patients with CNS-only disease progression receive whole brain radiotherapy (WBRT). After completion of WBRT, these patients also receive up to 4 additional courses of treatment. Patients with disease progression to sites other than the CNS or patients with SD who were previously untreated before study enrollment are removed from the study.
Quality of life is assessed at baseline, before each treatment course, and then annually for 3 years.
研究设计
- 研究类型
- Interventional
- 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
liposomal SN-38
Patients receive SN-38 liposome IV over 90 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response or patients with stable disease (SD) who were previously treated before study enrollment receive up to 4 additional courses of treatment. Patients with CNS-only disease progression receive whole brain radiotherapy (WBRT). After completion of WBRT, these patients also receive up to 4 additional courses of treatment. Patients with disease progression to sites other than the CNS or patients with SD who were previously untreated before study enrollment are removed from the study.
Quality of life is assessed at baseline, before each treatment course, and then annually for 3 years.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 2 years.
干预措施: liposomal SN-38 (Drug)
结局指标
主要结局
Tumor response measured by number of responses
时间窗: Up to 3 years
次要结局
- Change in quality of life (QOL) score over time(Up to 3 years)
- Time to disease progression(Up to 3 years)
- Survival time(Up to 3 years)