Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene in Patients With NSCLC
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- The Radiographic Response to Gefitinib
研究概览
简要总结
The purpose of this research study is to:
- see if gefitinib pills can shrink Stage 1 or 2 non-small cell lung cancers before surgery
- see if your non-small cell lung cancer has a mutation in a certain part of the EGFR gene
- see if patients whose tumor does shrink with gefitinib treatment are more likely to have a mutation in a certain part of the EGFR gene
- see if the pattern of protein expression in the blood is related to the tumor's sensitivity or resistance to gefitinib treatment.
- see if expression of certain genes in the tumor are related to the tumor's sensitivity or resistance to gefitinib treatment.
详细描述
This is a phase II, single institution trial to correlate gefitinib response and mutations in the protein-tyrosine kinase domain of the EGF receptor gene. The study will be conducted in patients with Stage I and II NSCLC who have been determined to be operable and resectable.
Patients must have 1 or more of the following features: never smoker or smoking history of < 15 pack years and/or features of bronchioloalveolar lung cancer. 50 patients will be enrolled on this study. Treatment will be with gefitinib for at least 21 days before surgery (depending on the timing of the surgery). Patients will discontinue gefitinib 2 days before their operation. For patients that demonstrate a radiographic response to gefitinib preoperatively and /or patients with mutations in the protein-tyrosine kinase domain of the EGF receptor gene (identified from the surgical sample), gefitinib will continue for 2 years post-surgery. Patients who do not have evidence of radiographic response or mutations in the protein-tyrosine kinase domain of the EGF receptor gene will be removed from 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologic confirmation of malignancy at Memorial Sloan-Kettering
- •Patients must have previously untreated stage I or II NSCLC (T11-2N0M0, T1-2N1M0, T3N0M0) and 1 of the following features: never smoker or < 15 pack year smoking history and/or bronchioloalveolar cancer (either pure BAC, BAC with focal invasion or adenocarcinoma with BAC features)
- •Patients must have been determined to be operable and resectable by the treating thoracic surgeon.
- •Age >18 years.
- •Measurable indicator lesions
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Pregnant or lactating women or women of childbearing potential not using effective contraception. Men participating in the trial must also use effective contraception when sexually active.
- •Patients may not be receiving any other investigational agents.
- •Any history of or evidence of interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).
研究组 & 干预措施
Treatment
干预措施: Gefitinib (Drug)
结局指标
主要结局
The Radiographic Response to Gefitinib
时间窗: 21 days
Radiographic response is defined as a minor response ( \> 25% decrease in the sum of the products of measured lesions)
次要结局
- Microarray Analysis to Identify Gene(s) or Gene Clusters That Exhibit Changes in Gene Expression; Time to Relapse and Overall Survival Data(2 years)