A Multicenter Phase II Trial of Carboplatin, Pemetrexed, and Bevacizumab Followed By Pemetrexed and Bevacizumab Maintenance Therapy in Patients With a Light or Never Smoking History
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- Progression-free Survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as carboplatin, 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 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 non-small cell lung cancer 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 III or stage IV non-small cell lung cancer who are light or never smokers.
详细描述
OBJECTIVES:
Primary
- To estimate the progression-free survival (PFS) of patients with advanced non-small cell lung cancer who are never or light smokers treated with carboplatin, pemetrexed disodium, and bevacizumab followed by pemetrexed disodium and bevacizumab maintenance therapy.
Secondary
- To estimate the overall survival (OS) of patients treated with this regimen.
- To estimate the toxicity of treatment using the NCI CTCAE version 3.0.
- To conduct an exploratory analysis of molecular markers, e.g., Kirsten rat sarcoma (KRAS) and epidermal growth factor receptor (EGFR) mutations, in patients with a never or light smoking history and to analyze any potential association with response, PFS, and OS.
- To assess response to second-line erlotinib hydrochloride therapy according to RECIST criteria.
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 —（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
Single Arm Trial
Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride
干预措施: bevacizumab (Biological)
Single Arm Trial
Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride
干预措施: carboplatin (Drug)
Single Arm Trial
Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride
干预措施: erlotinib hydrochloride (Drug)
Single Arm Trial
Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride
干预措施: pemetrexed disodium (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: 1400 days
Documented radiographic response per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. criteria each year, until subject death
次要结局
- Overall Survival(1400 days)
- Subjects Experiencing Toxicity(90 days)