A Clinical and Pharmacologic Study of the Combination of Erlotinib and Bexarotene in Resectable Clinical Stage I-II Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Participants With Change in Expression Level of EGFR.
研究概览
简要总结
The purpose of this study is to learn the effects on lung cancer of 2 new drugs, Tarceva and Targretin, given in combination before surgical removal of the tumor. Tarceva is approved by the Food and Drug Administration (FDA) for lung cancer. Targretin is approved for the treatment of cutaneous T-cell lymphoma. This combination of drugs is experimental.
详细描述
Erlotinib 150mg and bexarotene 400mg/m2 will be administered orally for 7-9 days prior to thoracotomy. Plasma samples will be collected on the day before surgery and along with tissue samples on the day of the thoracotomy. Analyses will be done on the resected specimen and it will be compared to the pre-study diagnostic specimen.
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
- •Resectable stage I or II non-small-cell lung cancer
- •Prior tissue biopsy (not cytology) available for research analysis
- •Adequate hepatic and renal function
排除标准
- •Prior chemotherapy or radiotherapy
研究组 & 干预措施
Erlotinib and Bexarotene
Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy.
干预措施: erlotinib (Tarceva) and bexarotene (Targretin) (Drug)
结局指标
主要结局
Number of Participants With Change in Expression Level of EGFR.
时间窗: Baseline and 9 days
Number of Participants With Change in Expression Level of Cyclin D1
时间窗: Baseline and 9 days
Number of Participants With Change in Expression Level of Phosphorylated EGFR (pEGFR)
时间窗: Baseline and 9 days
次要结局
- Tumor Tissue Concentrations of Erlotinib and Bexarotene and Correlation With Plasma Levels(At 9 days)
- Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response(Baseline and 9 days)
研究者
Konstantin Dragnev
Associate Professor of Medicine
Dartmouth-Hitchcock Medical Center