NCT00466284Unknown2 期
Phase II Trial of Tarceva Following Concurrent Chemo-Radiotherapy as First Line Therapy in Patients With Unresectable Non-Small Cell Lung Cancer
Grupo Gallego de Cancer de Pulmon1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2006年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
A open label non- randomized Phase II trial. It is anticipated that approximately 46 patients will be treated.
STUDY OBJECTIVES
Primary: Objective response rate
Secondary: Progression free survival, Overall survival and Safety of Tarceva
详细描述
Study Design: Phase II trial, open label, non-randomized and multicenter.
Expected total enrollment: 46
Study start: January, 2006
Study completation: January, 2008
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years.
- •Patients must have histologically confirmed diagnosis of non-small cell lung cancer, which is not surgically resectable (stage IA- IIIB).
- •Measurable disease.
- •Written informed consent must be obtained prior to the inclusion into the trial.
- •Karnofsky performance status of 80%.
- •Patients must have been treated with no prior chemotherapy or radioterapy.
- •Patients must have adequate bone marrow, liver and renal function.
- •Bone Marrow: WBC > 3000 x 103/mm3,
- •Platelets > 100 x 103/mm3,
- •Hgb > 10.0 gm/dl,
- •ANC >1500 x 103/mm3,
- •Hepatic:Bilirubin < 2 mg/dl (34 µmol/l); AST, ALT, and Alkaline Phosphatase < 5 x normal,
- •Renal:Creatinine < 1.5 mg/dl (132 µmol/l).
排除标准
- •Female patients who are pregnant or lactating.
- •Patients who have used other investigational agents within 21 days prior to study entry.
- •Patients who have received prior treatment with erlotinib or other anti-EGFR agent.
- •Significant comorbidity.
结局指标
主要结局
Objective response rate
次要结局
- Progression free survival
- Overall survival
- Safety of Tarceva
研究者
研究点 (1)
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