A Phase II-III Randomized Trial Pemetrexed-Cisplatin Chemotherapy With or Without Bevacizumab (Avastin), 15 mg/kg, for Malignant Pleural Mesothelioma (MPM)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 448
- 试验地点
- 78
- 主要终点
- % of patients with controled disease (responder and stable patients) at 6 months
研究概览
简要总结
Our hypothesis is that the addition of bevacizumab to the standard chemotherapy treatment of MPM will improve overall survival and quality of life beyond that achieved with chemotherapy alone.
详细描述
A phase II trial associating the reference chemotherapy (pemetrexed plus cisplatin) with bevacizumab is needed to ensure that no specific toxicity is induced by this association, and that this triplet have interesting activity. As pleural mesothélioma is a rare tumor, a phase III trial, using the survival data from the phase II part study, will be able to include a sufficient number of patients, in a reasonable period of time, to answer the question of efficacy of the anti-angiogenic triplet, providing the efficacy outcomes could be considered as favorable, at the end of the phase II part of the study.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Malignant, histologically proved, non resectable pleural Mesothelioma
- •In case of pleural effusion, a talc pleurodesis, although not recommended, is allowed in accordance with current local practice, at the time of diagnostic thorascopy, with inclusion CT scan performed after pleurodesis.
- •ECOG Performance status 0-2
- •Mesothelioma with only pleural effusion without uni- or bidimensionally measurable disease will be eligible (adapted RECIST criteria)
- •At least 18 years of age, less than 76 years of age
- •Radiation therapy of thoracocentis tract (3 x 7Gy) performed before beginning medical study treatment, and the interval between thoracoscopic procedure and radiation will not exceed 28 days
排除标准
- •Prior chemotherapy
- •Brain metastasis
- •History of cerebral vascular accident (CVA) or transient ischemic attack
研究组 & 干预措施
1
Standard Chemotherapy
干预措施: Standard Chemotherapy (Pemetrexed and Cisplatin) (Drug)
2
Standard Chemotherapy + bevacizumab (Avastin)
干预措施: Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab (Drug)
结局指标
主要结局
% of patients with controled disease (responder and stable patients) at 6 months
时间窗: 3-month
次要结局
- Overall Survival(month)
- Number of participants with treatment-related adverse events as assessed by CTCAE v3.0(month)