NCT00642733终止4 期
An Open Label Study to Evaluate the Effect of First Line Treatment With Tarceva in Combination With Gemcitabine on Overall Survival and Disease Progression in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 6
- 主要终点
- Overall survival; time to progression
研究概览
简要总结
This single arm study will assess the efficacy and safety of Tarceva + gemcitabine in patients with locally advanced, unresectable or metastatic pancreatic cancer. Patients will receive Tarceva 100mg po daily, in combination with gemcitabine 1000mg/m2 iv weekly for 8 weeks, followed by weekly for 3 weeks of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
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
- •adult patients, >=18 years of age;
- •pancreatic cancer, surgically unresectable or with metastases;
- •no previous chemotherapy (except concomitant with radiotherapy);
- •ECOG 0-2.
排除标准
- •pancreatic cancer without histologic or cytologic confirmation;
- •surgical resection possible;
- •previous chemotherapy not concomitant with radiotherapy;
- •ECOG 3-4.
研究组 & 干预措施
1
Experimental
干预措施: erlotinib [Tarceva] (Drug)
1
Experimental
干预措施: gemcitabine (Drug)
结局指标
主要结局
Overall survival; time to progression
时间窗: 6 months
次要结局
- Duration of response; disease-free survival(Event driven)
- AEs, lab parameters(Throughout study)
研究者
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