NCT01770795已完成2 期
A Phase II Trial of Genexol-PM and Gemcitabine in Patients With Advanced Non-small-cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
To evaluate the efficacy and safety Genexol-PM(CrEL-free polymeric micelle formulated paclitaxel)and gemcitabine in untreated metastatic NSCLC 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 18
- •histologically or cytologically confirmted non-small cell lung cancer
- •stage IIIb with pleural effusion or stage IV
- •ECOG PS 0-2
- •at least one measurable lesion
- •expected life span more than 3 months
- •normal bone marrow, liver, renal function
- •no prior chemotherapy or radiotherapy except for whole brain radiotherapy for symptomatic brain metastases
- •more than 6 months from the last adjuvant chemotherapy
排除标准
- •active infection
- •severe comorbitidies
- •pregnant or lactating women
- •other invasive malignancies
- •poorly controlled symptomatic brain metastases
研究组 & 干预措施
Genexol-PM/Gemcitabine
Experimental
干预措施: Genexol-PM/Gemcitabine (Drug)
结局指标
主要结局
Overall response rate
时间窗: one year
次要结局
- progression free survival(one year)
- overall survival(one year)
- toxicities(one year)
研究者
Eun Kyung Cho
Professor
Gachon University Gil Medical Center
研究点 (1)
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