A Phase II Study of Bevacizumab Plus Docetaxel and Gemcitabine in Subjects With Advanced, Previously Untreated, Non-Squamous 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
- 13
- 试验地点
- 4
- 主要终点
- Progression Free Survival(PFS)
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. Drugs used in chemotherapy, such as docetaxel and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with docetaxel and gemcitabine hydrochloride may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel and gemcitabine hydrochloride works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Estimate the 1-year progression-free survival rate in patients with stage IIIB, stage IV, or recurrent non-squamous cell non-small cell lung cancer treated with bevacizumab, docetaxel, and gemcitabine hydrochloride.
Secondary
- Evaluate the median time to progression in patients treated with this regimen.
- Estimate the response rate in patients treated with this regimen.
- Determine the median overall survival of patients treated with this regimen.
- Determine the incidence of adverse events associated with 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
- 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
Bevacizumab, Docetaxel, and Gemcitabine
Treatment repeats every 21 days for up to 6 courses.
干预措施: bevacizumab (Biological)
Bevacizumab, Docetaxel, and Gemcitabine
Treatment repeats every 21 days for up to 6 courses.
干预措施: docetaxel (Drug)
Bevacizumab, Docetaxel, and Gemcitabine
Treatment repeats every 21 days for up to 6 courses.
干预措施: gemcitabine hydrochloride (Drug)
结局指标
主要结局
Progression Free Survival(PFS)
时间窗: 1 year
PFS is defined as time to death or first occurrence of documented disease progression assessed by the investigator as per the RECIST guidelines (at lease a 20% increase in the diameter of a lesion, in addition to an absolute increase of 5mm). If no deaths occur prior to progression, this measure will be the same as the median time to progression.
次要结局
- Best Response(1 year)
- Median Time to Progression(1 year)
研究者
Nathan Pennell, MD, PhD
Principal Investigator
Case Comprehensive Cancer Center