A Phase II Study of Neoadjuvant Therapy With Docetaxel, Carboplatin, and Bevacizumab in Patients With Resectable Early Stage Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Clinical response rate by CT scan after 3 courses of induction treatment
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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 docetaxel and carboplatin together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving docetaxel and carboplatin together with bevacizumab works in treating patients with stage I, stage II, or stage III non-small cell lung cancer that can be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine the clinical response rate in patients with stage IB-IIIA non-small cell lung cancer treated with neoadjuvant docetaxel, carboplatin, and bevacizumab.
Secondary
- Determine the median and overall survival of patients treated with this regimen.
- Determine the safety profile of this regimen.
- Determine the time to treatment failure of patients treated with this regimen.
- Determine the pathologic response rate and the resectability rate in patients treated with this regimen.
- Correlate vascular endothelial growth factor (VEGF) levels or expression with response and 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 —（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
结局指标
主要结局
Clinical response rate by CT scan after 3 courses of induction treatment
时间窗: After 3 cycles of induction treatment
次要结局
- Pathologic response rate after 3 courses of induction treatment(After 3 cycles of induction treatment)
- Resectability rate after 3 courses of induction treatment(After 3 cycles of induction treatment)
- Median survival at 2 years after surgery(2 years after surgery)
- Safety after 3 courses of induction treatment(After 3 cycles of induction treatment)
- Overall survival at 2 years after surgery(2 years after surgery)
- Time to treatment failure within 2 years after surgery(2 years after surgery)
- Correlation of serum VEGF levels prior to neoadjuvant therapy with primary and secondary objectives prior to start of induction treatment(Before induction treatment)
- Correlation of serum VEGF expression in resected tumor with primary and secondary objectives(After surgical removal of tumor)
- Correlation of VEGF levels measured immediately after resection and after adjuvant bevacizumab therapy with primary and secondary objectives(After resection and after adjuvant bevacizumab)
- Assay additional downstream VEGF activation pathway markers(At any time during the study)