NCT00040183已完成3 期
A Randomized Placebo Controlled Study of OSI-774 (Tarceva (TM)) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
OSI Pharmaceuticals140 个研究点 分布在 6 个国家目标入组 569 人开始时间: 2001年11月29日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 569
- 试验地点
- 140
研究概览
简要总结
The purpose of this study is to determine if OSI-774 will improve overall survival when combined with a standard dose of the chemotherapy drug gemcitabine, to individuals with pancreatic cancer.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas;cancer which is unresectable, locally advanced or metastatic.
- •Must have evidence of disease (clinical or radiological). Male or female, 18 years or older. Patients may have received prior radiation treatment for management of local disease providing that disease progression has been documented.
- •All toxicities have resolved, and the last fraction of radiation treatment was completed at least 4 weeks prior to randomization.
- •Patients may not have received prior chemotherapy, other then 5FU (+/- folic acid) or gemcitabine given concurrently with radiation treatment as a 'radiosensitiser.'
排除标准
- 未提供
研究者
研究点 (140)
Loading locations...
相似试验
已完成
3 期
OSI-774 (Tarceva) in Treating Patients With Stage III or Stage IV Non-Small Cell Lung CancerCarcinoma, Non-small-cell LungNCT00036647OSI Pharmaceuticals731
已完成
2 期
Tarceva, Capecitabine and Oxaliplatin for Metastatic Colorectal CancerNeoplasm MetastasisColorectal CancerNCT00123851Dana-Farber Cancer Institute32
已完成
2 期
OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell CancerHead and Neck CancerNCT00076310M.D. Anderson Cancer Center50
已完成
2 期
Tarceva and Capecitabine for Pancreatic CancerNeoplasm MetastasisPancreatic CancerNCT00125021Dana-Farber Cancer Institute32
已完成
1 期
Erlotinib, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic CancerAdenocarcinoma of the PancreasRecurrent Pancreatic CancerStage II Pancreatic CancerStage III Pancreatic CancerNCT00063947National Cancer Institute (NCI)28