NCT00061451已完成2 期
ALIMTA Plus Gemcitabine as Front-line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer: A Phase II Clinical Trial
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 5
- 主要终点
- To assess the objective tumor response rate of gemcitabine plus pemetrexed in patients with advanced or metastatic non-small-cell lung cancer.
研究概览
简要总结
The purposes of this study are to determine:
- The safety of Pemetrexed plus Gemcitabine and any side effects that might be associated with the combination of these two drugs.
- Whether Pemetrexed plus Gemcitabine can help patients with non-small cell lung cancer live longer.
- Whether Pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how long.
- To see if patients feel better while taking Pemetrexed plus Gemcitabine.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Non-Small Cell Lung Cancer that can be treated with chemotherapy.
- •Have received no prior chemotherapy for Non-Small Cell Lung Cancer.
- •Have at least one measurable lesion.
- •Have an adequate performance status.
- •Sign an informed consent.
排除标准
- •A female who is pregnant or breastfeeding.
- •Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating Pemetrexed.
- •Treatment with radiation therapy within the last 4 weeks.
- •Brain metastasis that is uncontrolled.
- •Active infection or other serious condition.
结局指标
主要结局
To assess the objective tumor response rate of gemcitabine plus pemetrexed in patients with advanced or metastatic non-small-cell lung cancer.
次要结局
- To assess duration of response for responding patients
- To assess time to treatment failure for patients
- To assess time to objective tumor response for responding patients
- To assess progression free survival of patients
- To assess survival time for patients
- To characterize the toxicities of gemcitabine plus pemetrexed in this patient population
- To assess time to progressive disease for patients
研究者
研究点 (5)
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