NCT00061477已完成2 期
ALIMTA Plus Gemcitabine as Front-Line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma: 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
- 10
- 主要终点
- To determine the objective tumor response rate for pemetrexed plus gemcitabine every 21 days in patients with malignant pleural mesothelioma who have not received prior chemotherapy
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 mesothelioma 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 mesothelioma that can be treated with chemotherapy
- •Have received no prior chemotherapy for mesothelioma
- •Have at least one measurable lesion
- •Have an adequate performance status
- •Sign an informed consent
排除标准
- •Previous treatment with chemotherapy for mesothelioma
- •Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating Pemetrexed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 determine the objective tumor response rate for pemetrexed plus gemcitabine every 21 days in patients with malignant pleural mesothelioma who have not received prior chemotherapy
次要结局
- To assess time to objective tumor response for responding patients;To assess duration of response for responding patients;To assess time to treatment failure;To assess time to progressive disease
- To assess progression-free survival;To assess overall survival;To determine toxicities of pemetrexed in combination with gemcitabine in this population
研究者
研究点 (10)
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