Phase II Study of ABI-007 Plus Sunitinib as First Line Treatment for Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Response rate
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. Sunitinib 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 sunitinib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving paclitaxel albumin-stabilized nanoparticle formulation together with sunitinib works as first-line therapy in treating patients with stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- To determine the tumor response rate in patients with stage IV non-small cell lung cancer treated with paclitaxel albumin-stabilized nanoparticle formulation and sunitinib malate as first-line therapy.
Secondary
- To determine the time to objective tumor response and duration of response in responding patients.
- To determine the time to treatment failure and overall survival of these patients.
- To characterize the toxicities of 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
Stage IV Non-Small Cell Lung Cancer Patients
Patients with stage IV non-small cell lung cancer treated with paclitaxel albumin-stabilized nanoparticle formulation and sunitinib malate as first-line therapy.
干预措施: paclitaxel albumin-stabilized nanoparticle formulation (Drug)
Stage IV Non-Small Cell Lung Cancer Patients
Patients with stage IV non-small cell lung cancer treated with paclitaxel albumin-stabilized nanoparticle formulation and sunitinib malate as first-line therapy.
干预措施: sunitinib malate (Drug)
结局指标
主要结局
Response rate
时间窗: 1 Year
次要结局
- Time to treatment failure(1 Year)
- Toxicity and adverse events as assessed by NCI CTCAE v3.0(1 Year)
- Overall survival(1 Year)
- Time to objective tumor response as assessed by RECIST criteria(1 Year)
- Duration of response(1 Year)