NCT02590055Unknown2 期
Phase 2 Study of Gemcitabine and Docetaxel Combination Chemotherapy in Patients With Carcinoma of Unknown Primary
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
It's a phase 2, single arm study of gemcitabine an docetaxel combination in patients with carcinoma of unknown primary.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathologically confirmed patients with carcinoma of unknown primary
- •unfavorable type of CUP
- •ECOG PS 0-2
- •more than 1 evaluable lesion
- •life expectancy > 12 weeks
- •no prior history of chemotherapy
- •more than 2 weeks after surgery or radiotherapy
- •proper organ function
- •written informed consent
排除标准
- •favorable group CUP
- •squamous cell carcinoma in the cervical or inguinal LN only women with axillary LN metastasis only women with peritoneal carcinomatosis only well-differentiated neuroendocrine tumors poorly-differentiated tumors with midline tumor or elevated human HCG/AFP men with adenocarcinoma and elevated PSA
- •severe, unstable heart disease
- •uncontrolled systemic disease (DM, HTN, hypothyroidism, infection...)
- •pregnant or feeding women
- •current CNS tumor (except total removal or WBRT/GKS done)
研究组 & 干预措施
Intervention arm
Experimental
D1, 8 Gemcitabine 1000mg/m2 IV over 30 minutes D1, 8 Docetaxel 35mg/m2 IV over 1hr
干预措施: gemcitabine/docetaxel combination (Drug)
结局指标
主要结局
Overall survival
时间窗: one year after later patients enrolled
次要结局
未报告次要终点
研究者
Su Jin Lee
MD, PhD
Samsung Medical Center
研究点 (1)
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