NCT01149122已完成3 期
Phase III Study of Gemcitabine/Oxaliplatin (GEMOX) With or Without Erlotinib in Unresectable, Metastatic Biliary Tract Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of this study is to determine whether Gemcitabine/Oxaliplatin (GEMOX) with or without Erlotinib (Tarceva) is effective in the treatment of unresectable, metastatic biliary tract carcinoma.
详细描述
This is a phase III study of Gemcitabine/Oxaliplatin (GEMOX) with or without Erlotinib in unresectable, metastatic biliary tract carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 or cytologically confirmed adenocarcinoma of biliary tract
- •unresectable or metastatic
- •ECOG performance status of 0~2
- •measurable or evaluable lesion per RECIST criteria
- •adequate marrow, hepatic, renal and cardiac functions
- •no prior chemotherapy or molecularly targeted therapy for the advanced biliary carcinoma (prior adjuvant chemotherapy will be allowed if administered ≥ 6 months from the study entry)
- •provision of a signed written informed consent
排除标准
- •severe co-morbid illness and/or active infections
- •pregnant or lactating women
- •active CNS metastases not controllable with radiotherapy or corticosteroids
- •known history of hypersensitivity to study drugs
- •prior exposure to EGFR tyrosine kinase inhibitor
研究组 & 干预措施
Gemcitabine/Oxaliplatin with Erlotinib
Active Comparator
干预措施: Gemcitabine/Oxaliplatin with Erlotinib (Tarceva) (Drug)
Gemcitabine/Oxaliplatin without Erlotinib
Active Comparator
干预措施: Gemcitabine/Oxaliplatin (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: every 6 weeks
次要结局
- Safety profile(24 months)
- Response rate(24 months)
- Duration of response(24 months)
- Time to progression(24 months)
- Overall survival(24 months)
- Correlative analyses: EGFR mutation, EGFR amplification, akt expression, EGFR polymorphism analyses(24 months)
研究者
研究点 (1)
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