NCT02242409终止2 期
A Phase II Study of Gemcitabine and Nanoparticle-Bound Paclitaxel as Second Line Therapy in Patients With Metastatic Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- 4 month progression free survival
研究概览
简要总结
A Phase II trial of gemcitabine plus nab-paclitaxel in the second line setting
详细描述
This is an open label Phase II study to evaluate the clinical activity of the combination of gemcitabine and nab-paclitaxel (abraxane) as second line treatment in patients with metastatic pancreatic cancer who have received non-gemcitabine-based chemotherapy in the first line setting. All patients will receive both drugs on Days 1, 8, 15 every 28 days. The hypothesis is that this combination will have a 4-month progression free survival of 70% or higher.
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
- •Histologically confirmed metastatic adenocarcinoma of the pancreas
- •Progression on first line non-gemcitabine based therapy for metastatic or relapsed disease
- •Radiographically measurable or evaluable disease
- •Age >/= 18 years
- •ECOG performance status 0-2
- •Adequate hepatic, bone marrow and renal function
排除标准
- •Prior gemcitabine-based chemotherapy in the first line setting
- •No active severe infection, or known chronic infection with HIV or hepatitis B virus
- •No cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months
- •No women who are pregnant or breastfeeding, and no women of childbearing potential without using dual forms of contraception
- •Patients with known CNS metastases
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or nab-paclitaxel
- •Anticipated patient survival under 2 months
研究组 & 干预措施
Gemcitabine/abraxane
Experimental
Gemcitabine and Abraxane
干预措施: Gemcitabine and Abraxane (Drug)
结局指标
主要结局
4 month progression free survival
时间窗: 2.5 years
The proportion of patients at 4 months from study entry with progression or death
次要结局
- Disease control rate(2.5 years)
- Progression Free Survival(2.5 years)
- Overall Survival(3 years)
研究者
研究点 (1)
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Unknown
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