NCT00190762已完成3 期
A Randomized Phase 3 Trial Comparing ALIMTA Plus Best Supportive Care Versus Best Supportive Care Alone in Previously Treated Patients With Locally Advanced or Metastatic Malignant Pleural Mesothelioma
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- The primary objective of this study is to compare the overall survival following treatment with Pemetrexed plus best supportive care versus best supportive care alone
研究概览
简要总结
Based on results from earlier clinical trials, Pemetrexed may have antitumor activity as a first-line agent in the treatment of mesothelioma. Given this, it is hypothesized that Pemetrexed may be active in second-line mesothelioma in which the standard treatment is best supportive care. This study will compare survival of previously treated patients with malignant pleural mesothelioma who receive Pemetrexed plus best supportive care to the survival of similar patients who receive best supportive care alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologically proven diagnosis of mesothelioma of the pleura.
- •received only one prior systemic chemotherapy regimen for advanced or metastatic disease
- •Performance status of 70 or higher on the Karnofsky Performance Status Scale
- •Males or females at least 18 years of age
- •Adequate organ function
排除标准
- •Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy
- •Pregnancy or breastfeeding
- •Brain metastasis
- •Prior treatment with Pemetrexed
- •Inability or unwillingness to take folic acid or vitamin B12 supplementation
结局指标
主要结局
The primary objective of this study is to compare the overall survival following treatment with Pemetrexed plus best supportive care versus best supportive care alone
次要结局
- To characterize and compare the toxicities of Pemetrexed/best supportive care and best supportive care alone in this patient population;to determine the objective-tumor response rate
- to compare time to event efficacy variables of both arms including:duration of response,time to objective tumor response,time to treatment failure,time to documented disease progression,progression-free survival
- to compare changes in the average symptom burden index between the Pemetrexed/best supportive care and best supportive care arms
研究者
研究点 (2)
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