A Phase II Study of OSI-774 (Tarceva) in Elderly Subjects With Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- To determine how well non-small cell lung cancer cells in the body respond to OSI-774
研究概览
简要总结
The primary purpose of this study is to determine whether the drug OSI-774 is less toxic and potentially as good as or better than standard chemotherapy drugs, when given to subjects with non-small cell lung cancer, who are 70 years of age or older.
详细描述
Patients will receive OSI-774 once daily without interruption. There are no pre-determined number of cycles or planned dose interruptions. For the purposes of evaluation, toxicity and efficacy, a four week (28 day period) will be considered 1 cycle.
Patients will continue to receive OSI-774 until they develop progressive disease, unacceptable side-effects or wish to withdraw from the study.
Patients will have radiographic evaluations after every two cycles of therapy. After cycle 2, patients will also be evaluated by FDG-PET scanning.
Patients will also be asked to fill out a Lung Cancer Symptom Scale (LCSS) on the first day of each cycle.
Bloodwork will also be performed on day 1 of each cycle as well as at the end of the study.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 70 years of age or older
- •Stage IV or IIIB non-small cell lung cancer (NSCLC)
- •Measurable tumor(s)
- •Three or more weeks since prior radiation therapy
- •Three or more weeks since prior major surgery
- •Must at least be able to walk and capable of taking care of oneself although unable to carry out work activities.
- •Must be up and about more than 50% of waking hours.
- •Life expectancy of 8 weeks or more
- •Blood tests that show kidneys, liver and bone marrow to be working adequately
- •Completely healed from previous oncologic or other major surgery
排除标准
- •Prior chemotherapy regimen for non-small cell lung cancer
- •Prior exposure to OSI-774 or similar treatments such as trastuzumab, ZD1839, C225, etc.
- •Uncontrolled central nervous system metastases
- •Concurrent active cancer
- •Malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
- •Prior chemotherapy for any malignant disease
- •Difficulty swallowing
- •A disease or disorder that interferes with ability to digest and absorb food
- •A medical condition that could make it unsafe for patient to participate in this study
研究组 & 干预措施
Tarceva
Chemotherapy Single Agent Systemic
干预措施: OSI-774 (Tarceva) (Drug)
结局指标
主要结局
To determine how well non-small cell lung cancer cells in the body respond to OSI-774
时间窗: 2 years
To determine the survival rate of patients treated with OSI-774
次要结局
- To see how OSI-774 affects overall quality of life(2 years)
- To determine the safety of OSI-774 in people 70 years of age or older(2 years)
研究者
Pasi A. Janne, MD, PhD
Associate Professor, Medicine
Dana-Farber Cancer Institute