Phase I Study of Bevacizumab in Combination With Everolimus and Erlotinib in Advanced Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose
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. Erlotinib and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and everolimus may also block blood flow to the tumor. Giving everolimus and erlotinib together with bevacizumab may kill more tumor cells.
PURPOSE: This randomized phase I trial is studying the side effects and best dose of erlotinib and everolimus when given together with bevacizumab in treating patients with advanced solid tumors.
详细描述
OBJECTIVES:
Primary
- Estimate the maximum tolerated dose (MTD)/recommended phase II regimen of everolimus and erlotinib hydrochloride when given with bevacizumab in patients with advanced solid tumors.
- Evaluate safety of bevacizumab, everolimus, and erlotinib hydrochloride in these patients.
Secondary
- Describe the impact of this combination therapy on dermal wound angiogenesis and inhibition of vascular endothelial growth factor receptor 1 (VEGFR1), mTOR/p70S6K, and other related markers in granulation tissue.
- Evaluate clinical activity (partial response, complete response, or stable disease > 6 months) associated 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
研究组 & 干预措施
Bevacizumab, Everolimus, and Erlotinib
Dose Level Dose Bevacizumab (mg/kg q2wks) Everolimus (mg daily) Erlotinib (mg daily) -1 5 5 ---
- 10 5 ---
- 10 10 ---
- 10* 10* 75
- 10* 10* 150
干预措施: erlotinib hydrochloride (Drug)
Bevacizumab, Everolimus, and Erlotinib
Dose Level Dose Bevacizumab (mg/kg q2wks) Everolimus (mg daily) Erlotinib (mg daily) -1 5 5 ---
- 10 5 ---
- 10 10 ---
- 10* 10* 75
- 10* 10* 150
干预措施: bevacizumab (Biological)
Bevacizumab, Everolimus, and Erlotinib
Dose Level Dose Bevacizumab (mg/kg q2wks) Everolimus (mg daily) Erlotinib (mg daily) -1 5 5 ---
- 10 5 ---
- 10 10 ---
- 10* 10* 75
- 10* 10* 150
干预措施: everolimus (Drug)
结局指标
主要结局
Maximum Tolerated Dose
时间窗: Until study completion
Its primary objective is to estimate the MTD/recommended phase II dose combination or regimen
次要结局
- Safety(Until study completion)
研究者
Herbert Hurwitz, MD
Associate Professor
Duke University