NCT00061464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
- 4
- 主要终点
- To determine the tumor response rate for pemetrexed plus gemcitabine in patients with locally advanced or metastatic (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC).
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- •Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating pemetrexed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 1-2 weeks
- •Brain metastasis that is uncontrolled
- •Active infection or other serious condition
结局指标
主要结局
To determine the tumor response rate for pemetrexed plus gemcitabine in patients with locally advanced or metastatic (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC).
次要结局
- To measure time-to-event efficacy variables including:
- time to objective tumor response for responding patients
- duration of response for responding patients
- time to treatment failure
- time to progressive disease
- progression-free survival
- overall survival
- To characterize the quantitative and qualitative toxicities of pemetrexed plus gemcitabine in this patient population.
研究者
研究点 (4)
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