Phase II Trial of Carboplatin and Pemetrexed Plus Bevacizumab in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 5
- 主要终点
- Median Progression Free Survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as carboplatin and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving carboplatin and pemetrexed disodium together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving carboplatin and pemetrexed disodium together with bevacizumab works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the median time to disease progression in patients with stage IIIB or IV or recurrent non-squamous cell non-small cell lung cancer treated with carboplatin, pemetrexed disodium, and bevacizumab.
Secondary
- Determine the response rate and duration of response in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the overall survival of patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment Arm
Carboplatin + pemetrexed + bevacizumab
干预措施: bevacizumab (Biological)
Treatment Arm
Carboplatin + pemetrexed + bevacizumab
干预措施: carboplatin (Drug)
Treatment Arm
Carboplatin + pemetrexed + bevacizumab
干预措施: pemetrexed (Drug)
结局指标
主要结局
Median Progression Free Survival
时间窗: Approximately every 3 weeks until disease progression or death. Median follow up of 13 months (range 0.8 to 34.4 months)
Progression Free Survival (PFS) in patients treated with the combination of carboplatin, pemetrexed and bevacizumab is defined as the time from registration to the time of documented disease progression or death from any cause. Patients that were lost to follow up or withdrew consent were censored at that point.
次要结局
- Overall Response Rate(Every two cycles until disease progression. Median follow up of 13 months (range 0.8 to 34.4 months))
- Toxicity of Carboplatin, Pemetrexed and Bevacizumab Combination Treatment(From treatment initiation, at the beginning of each cycle where one cycle equals 21 days until 30 days post treatment (range of cycles 1-51))
- Overall Survival Rate(During treatment and then every 3 months x 2 years, then every 6 months x 3 years or until death.)
- Duration of Response(From documentation of response, every two cycles (1 cycle = 21 days) until progressive disease with range of cycles completed 1-51.)