NCT00305786已完成2 期
Phase II Study of Oxaliplatin in Combination With Gemcitabine for 2 Line Treatment of NSCLC Patients With Advanced and Metastatic Disease
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Response rate as measured by RECIST criteria
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works as second-line therapy in treating patients with stage III or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy and safety of gemcitabine hydrochloride and oxaliplatin as second-line chemotherapy in patients with stage IIIB or IV non-small cell lung cancer.
- Determine overall response in patients treated with this regimen.
Secondary
- Determine time to progression, time to treatment failure, and overall survival of these patients.
- Determine the type, frequency, severity, timing, and relatedness of all adverse events during treatment and for 30 days after completion of study treatment.
- Assess the quality of life of these patients.
- Determine the expression of RRM1 and ERCC1 in peripheral blood mononuclear cells from these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 120 Years（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
结局指标
主要结局
Response rate as measured by RECIST criteria
时间窗: At study completion
次要结局
- Toxicity as monitored by DSMC(At study completion)
研究者
研究点 (4)
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