Phase I/II Study of Weekly Abraxane and RAD001 in Women With Locally Advanced or Metastatic Breast Cancer. A Study of the Cancer Institute of New Jersey Oncology Group (CINJOG)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 3
- 主要终点
- To Determine the Maximum Tolerated Dose (MTD) of RAD001 in Combination of Weekly Abraxane and Determine the Phase II Dose of RAD001.
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving paclitaxel albumin-stabilized nanoparticle formulation together with everolimus may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when given together with paclitaxel albumin-stabilized nanoparticle formulation and to see how well it works in treating women with locally advanced or metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- To determine the maximum tolerated dose and recommended phase II dose of everolimus when administered in combination with paclitaxel albumin-stabilized nanoparticle formulation in women with locally advanced or metastatic breast cancer. (Phase I)
- To determine the antitumor activity of this regimen, as measured by clinical tumor response according to RECIST criteria, in these patients. (Phase II)
Secondary
- To determine the safety and tolerability of everolimus when administered at the recommended phase II dose in combination with paclitaxel albumin-stabilized nanoparticle formulation 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
- Female
- 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
Phase I / Phase II
Phase I:
- Abraxane will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle.
- RAD001 will be given by tablet. The first group of patients will receive RAD001 once daily depending on side effects seen drug could be increased later to twice a day for a 28 day cycle.
Once a safe and effective drug range is established, the study moves into Phase II.
Phase II:
The maximum tolerated dose (established in Phase I) will be given as scheduled below and we will measure the effectiveness of the study drug combination.
- Abraxane will be given by IV (intravenous infusion) for 30 minutes on the first day of the first three weeks of each 28 day cycle (Day 1, Day 8, and Day 15 of each cycle).
- RAD001 will be given by tablet based on the dose established in the Phase I part of the study.
干预措施: everolimus (Drug)
Phase I / Phase II
Phase I:
- Abraxane will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle.
- RAD001 will be given by tablet. The first group of patients will receive RAD001 once daily depending on side effects seen drug could be increased later to twice a day for a 28 day cycle.
Once a safe and effective drug range is established, the study moves into Phase II.
Phase II:
The maximum tolerated dose (established in Phase I) will be given as scheduled below and we will measure the effectiveness of the study drug combination.
- Abraxane will be given by IV (intravenous infusion) for 30 minutes on the first day of the first three weeks of each 28 day cycle (Day 1, Day 8, and Day 15 of each cycle).
- RAD001 will be given by tablet based on the dose established in the Phase I part of the study.
干预措施: abraxane (Drug)
结局指标
主要结局
To Determine the Maximum Tolerated Dose (MTD) of RAD001 in Combination of Weekly Abraxane and Determine the Phase II Dose of RAD001.
时间窗: 5 yrs
次要结局
未报告次要终点
研究者
Deborah Toppmeyer, MD
Professor, CINJ
Rutgers, The State University of New Jersey