NCT00619242终止不适用
A Pilot Study of the Effect of Sorafenib on Molecular Biomarkers in Barrett's Esophagus With High Grade Dysplasia
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Ki-67
研究概览
简要总结
To determine whether sorafenib is able to change pre-cancerous cells in a way that we believe is important in the progression of cancer.
详细描述
To characterize the effects of sorafenib on specific molecular markers in patients with Barrett's esophagus and high grade intraepithelial neoplasia (HGIN) or carcinoma in situ (CIS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG performance status 0-2
- •Life expectancy of greater than 12 months
- •No prior history of esophageal surgery or endoscopic treatment of dysplasia
- •No prior exposure to sorafenib
- •Patients may not be receiving any other investigational agents or any concomitant antineoplastic therapy, with the exception of androgen ablating agents (for patients with prior prostate cancer)
- •Age 18 years.
- •Patients must have adequate organ and marrow function as defined below:
- •hemoglobin: 8.5 g/dL
- •absolute neutrophil count: 1,500/L
- •platelets: 100,000/L (greater than 35,000/L without transfusion for less than 1 X the institutional upper limit of normal)
- •creatinine less than 1.5 X institutional upper limit of normal
- •Ability to understand and the willingness to sign a written informed consent.
排除标准
- •A patient will be withdrawn from the study if any of the following events occur while on therapy:
- •Interruption of scheduled therapy for greater than 7 days
- •Intolerable adverse effects which are judged by the investigator to be either physically or psychologically detrimental to the patient
- •Patient decision to discontinue treatment
- •Pregnancy
- •Patient non-compliance with therapy administration
- •Grade 3 or 4 NCI-CTC toxicity attributable to sorafenib
- •Treatment with other chemotherapeutic or investigational anti-neoplastic drugs
- •Disease progression
- •HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with sorafenib.Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
研究组 & 干预措施
sorafenib
Experimental
sorafenib 2 tablets by mouth
干预措施: sorafenib (Drug)
结局指标
主要结局
Ki-67
时间窗: Two weeks
Biomarker. Change in Ki-67 staining between pre- and on-therapy biopsies in patients with Barrett's esophagus.
次要结局
未报告次要终点
研究者
研究点 (1)
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