Multicenter Phase II Trial of OSI-774 (Erlotinib, Tarceva) in Patients With Advanced Bronchioalveolar Cell Lung Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Major objective response rate (complete response and partial response)
研究概览
简要总结
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with advanced non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the major objective response rate (partial response and complete response) in patients with advanced bronchoalveolar cell non-small cell lung cancer treated with erlotinib hydrochloride.
Secondary
- Assess the quality of life of patients treated with this regimen.
- Determine the duration of response and time to disease progression in patients treated with this regimen.
- Determine the median survival of patients treated with this regimen.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Therapeutic Intervention
Patients will receive erlotinib (OSI-774) 150 mg daily by mouth. If specified toxicities occurs, the dose may be reduced.
干预措施: erlotinib hydrochloride (Drug)
结局指标
主要结局
Major objective response rate (complete response and partial response)
时间窗: At 4 weeks and then every 8 weeks
Per Response Evaluation in Solid Tumors (RECIST) criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions
次要结局
- Worst grade toxicity(weekly for 4 weeks, then every 8 weeks to discontinuation of drug)
- Quality of life as measured by the Lung Cancer Symptom Scale for patients(baseline, every week for 5 weeks, and then every 4 weeks)
- Survival(from study entry to date of death or last date known alive)
研究者
William Pao, MD
Professor of Medicine, Cancer Biology, & Pathology/ Microbiology/ Immunology; Director, Division of Hematology and Oncology; Ingram Professor of Cancer Research; Director, Personalized Cancer Medicine; Medical Oncologist
Vanderbilt-Ingram Cancer Center