NCT00922896已完成2 期
A Phase II Trial of Erlotinib in Combination With Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 3
- 主要终点
- To assess the response rate associated with gemcitabine, erlotinib and cisplatin in patients with advanced pancreatic cancer
研究概览
简要总结
The purpose of this study is to determine the response rate of gemcitabine, cisplatin and erlotinib in metastatic pancreatic cancer.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than 18
- •Younger than 75
- •ECOG performance status 0 or 1
- •Histologically confirmed adenocarcinoma of the pancreas
- •Metastatic pancreatic cancer
- •No prior chemotherapy for metastatic pancreatic cancer
- •A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in Spiral CT or multidetector CT (MD CT)
排除标准
- •A patient with no measurable disease
- •A patient who received previous palliative chemotherapy for pancreatic cancer
- •A patient with locally advanced pancreatic cancer
- •A patient who received adjuvant chemotherapy for pancreatic cancer within 1 year
- •A patient with previous active or passive immunotherapy
- •A pregnant or lactating patient
研究组 & 干预措施
GPE
Experimental
Gemcitabine-Cisplatin-Erlotinib
干预措施: Gemcitabine, Cisplatin, Erlotinib (Tarceva) (Drug)
结局指标
主要结局
To assess the response rate associated with gemcitabine, erlotinib and cisplatin in patients with advanced pancreatic cancer
时间窗: Clinically assessed every cycle (month) and radiologically assessed every 2 cycles (6 weeks) with CT scan
次要结局
未报告次要终点
研究者
Jung Hun Kang
Associate Professor
Gyeongsang National University Hospital
研究点 (3)
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