NCT01608841Unknown2 期
The Role of Epidermal Growth Factor Receptor (EGFR) Mutations in Pancreatic Cancer Patients Receiving Gemcitabine With or Without Erlotinib
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- disease control rate
研究概览
简要总结
The purpose of this study is to investigate the influence of epidermal growth factor receptor mutations on the efficacy of erlotinib and gemcitabine in metastatic pancreatic cancer.
详细描述
The influence of EGFR mutations on the efficacy of treatment with and without erlotinib in metastatic pancreatic cancer is to be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •metastatic chemotherapy-naïve pancreatic cancer patients
- •histologically confirmed
- •adequate samples for analysis
- •Eastern Cooperative Oncology Group (ECOG) performance status <= 2
- •absolute neutrophil count (ANC) >= 1,500/mm3
- •platelet count >= 100,000/mm3
- •serum creatinine <= 1.5 mg/dL
- •aspartate aminotransferase (AST)
- •alanine aminotransferase (ALT) < 5 times the upper limit of normal
排除标准
- •absence of any other malignancy or serious medical or psychological illness that would preclude informed consent
研究组 & 干预措施
Gemcitabine plus erlotinib
Experimental
干预措施: Erlotinib (Drug)
结局指标
主要结局
disease control rate
时间窗: eight weeks
次要结局
- response rate(eight weeks)
- overall survival(one day)
- progression-free survival(one day)
研究者
vghtpe user
Attending Physician
Taipei Veterans General Hospital, Taiwan
研究点 (1)
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