Evaluation of Bevacizumab and Weekly Docetaxel in Elderly (≥ 75 Years) Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 3
- 主要终点
- Survival
研究概览
简要总结
RATIONALE: 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. Drugs used in chemotherapy, such as docetaxel, also work in different ways to kill tumor cells or stop them from growing. Giving bevacizumab together with docetaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel works in treating older patients with stage III or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- To determine the proportion of elderly (≥ 75 years of age) patients with stage III or IV non-small cell lung cancer surviving for at least 6 months when treated with a combination of bevacizumab and weekly docetaxel.
Secondary
- To assess the progression-free and overall survival of patients treated with this regimen.
- To determine the response rate in patients treated with this regimen.
- To assess the toxicity of this regimen in these patients.
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
- 75 Years 至 120 Years（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
Avastin & Docetaxel
Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15
干预措施: bevacizumab (Biological)
Avastin & Docetaxel
Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15
干预措施: docetaxel (Drug)
结局指标
主要结局
Survival
时间窗: 6 months when treated with combination of Avastin and weekly docetaxel
次要结局
- Progression-free Survival(6 months when treated with combination of Avastin and weekly docetaxel)
- Overall Survival(4 weeks after removal from study or until death)
- Response Rate(Every 8 weeks)
- Toxicity According to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0(1st and 2nd week of each 21 day cycle, up to six cycles.)
研究者
Shirish M. Gadgeel
Principal Investigator
Barbara Ann Karmanos Cancer Institute