A Phase II Study of Erlotinib (OSI-774); Tarceva in Women With Previously Untreated Advance Adenocarcinoma of the Lung
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 3
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The purpose of this trial is to figure out what effects (good or bad) the investigational drug agent called Tarceva (erlotinib; OSI-774) has on women with previously untreated adenocarcinoma.
详细描述
Patients will start taking Tarceva daily by mouth on Day 1 and will continue taking this medication daily at home, until participation in the study ends.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of adenocarcinoma of the lung
- •Patient has had at least one core biopsy of her tumor
- •Must be willing to undergo epidermal growth factor receptor (EGFR) mutation testing of her tumor
- •Stage four (IV) or three (III) B non-small cell lung cancer
- •Non-smoker or former smoker. Non-smoker is defined as a person who smoked 100 or less cigarettes in her lifetime while a former smoker is defined as a person who has quit smoking one or more years ago.
- •Three or more weeks since last radiation therapy
- •Three or more weeks since last major surgery
- •Must at least be able to walk and capable of taking care of herself although unable to carry out work activities
- •Life expectancy of 8 weeks or more
- •Blood tests that show kidneys, liver and bone marrow to be working adequately
- •Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the entire time enrolled in study
排除标准
- •Prior exposure to Tarceva (OSI-774, erlotinib)
- •Uncontrolled central nervous system problems
- •Prior chemotherapy regimen
- •Difficulty swallowing
- •A disease or disorder that interferes with ability to digest and absorb food
- •Incomplete healing of previous oncologic or other major surgery
- •Significant medical history or unstable medical condition such as heart failure, active infection, uncontrolled high blood pressure
- •Pregnant or breast feeding
- •A medical condition that could make it unsafe for patient to participate in this study
研究组 & 干预措施
Erlotinib
Erlotinib: 150 mg orally once daily without interruption Cycle duration considered 4 weeks and treatment duration indefinite until disease progression, unacceptable toxicity or withdrawal for other reasons.
干预措施: Erlotinib (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months.
ORR is defined as the percentage of participants who achieve partial response (PR) or better on treatment based on RECIST 1.0 criteria: For target lesions, complete response (CR) is disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD (both require a minimum of 4 weeks). Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or appearance of one or more new target lesions. Stable disease (SD) is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions.
次要结局
- Overall Survival by EGFR Mutation Status(In this study cohort, participants were followed for survival up to 155 months.)
- Overall Response Rate (ORR) by EGFR Mutation Status(In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months.)
- Overall Survival (OS)(In this study cohort, participants were followed for survival up to 155 months.)
研究者
Pasi A. Janne, MD, PhD
Associate Professor, Medicine
Dana-Farber Cancer Institute