Phase II Trial OF Oxaliplatin and Gemcitabine With Bevacizumab in Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- To determine the overall time to progression of the combination regimen of Gemcitabine, Oxaliplatin and Bevacizumab as first-line treatment in patients with Stage IIIB and IV non-small cell lung cancer.
研究概览
简要总结
The combination of oxaliplatin and gemcitabine has proven activity in advanced non-small cell lung cancer (NSCLC). Due to its favorable toxicity profile, this combination is optimal for adding new agents. Bevacizumab is an anti-VEGF monoclonal antibody that has also shown favorable results in advanced NSCLC. This study will add bevacizumab to oxaliplatin and gemcitabine as first line treatment in patients with Stage IIIB and IV NSCLC.
详细描述
STUDY OBJECTIVES:
Primary:
To determine the overall time to progression of the combination regimen of Gemcitabine, Oxaliplatin and Bevacizumab as first-line treatment in patients with Stage IIIB and IV non-small cell lung cancer.
Secondary
- To determine the overall response rate
- To determine the overall survival.
- To determine the toxicity of Gemcitabine, Oxaliplatin given in combination with Bevacizumab
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed non-small cell lung cancer, EXCEPT squamous cell cancer
- •Stage IIIB or IV disease
- •ECOG PS 0-1
- •No prior treatment
- •No brain metastases
- •Must have measurable disease
排除标准
- •Deep vein thromboses or pulmonary embolus within 1 year
- •History of gross hemoptysis
结局指标
主要结局
To determine the overall time to progression of the combination regimen of Gemcitabine, Oxaliplatin and Bevacizumab as first-line treatment in patients with Stage IIIB and IV non-small cell lung cancer.
时间窗: Prospective
次要结局
- • To determine the overall response rate • To determine the overall survival. • To determine the toxicity of Gemcitabine, Oxaliplatin given in combination with Bevacizumab(Prospective)