A Phase II Study of Erlotinib (Tarceva®) in Patients With Muscle-Invasive Bladder Cancer Undergoing Radical Cystectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- EGFR Activation Signal (AKT2) Expression to Predict Sensitivity to Erlotinib
研究概览
简要总结
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving erlotinib after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well erlotinib works when given before and after surgery in treating patients with muscle-invasive bladder cancer.
详细描述
OBJECTIVES:
Primary
- Determine the effect of neoadjuvant erlotinib hydrochloride on histopathological, molecular, and genetic correlates in patients undergoing radical cystectomy for muscle-invasive bladder cancer.
Secondary
- Determine the pathological complete response rate in surgical specimens from patients treated with this drug.
- Determine recurrence and progression rates after cystectomy (up to 2 years after surgery) in patients treated with neoadjuvant and adjuvant erlotinib hydrochloride.
- Determine 2- and 5-year disease-free, disease-specific, and overall survival rates in patients treated with this drug.
- Determine the safety of this drug in these patients.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Erlotinib
erlotinib given before and after transurethral resection of a bladder tumor, TURBT
干预措施: Erlotinib (Drug)
Erlotinib
erlotinib given before and after transurethral resection of a bladder tumor, TURBT
干预措施: Radical Cystectomy (Procedure)
结局指标
主要结局
EGFR Activation Signal (AKT2) Expression to Predict Sensitivity to Erlotinib
时间窗: 4 weeks before treatment and 4 weeks post treatment
Determine the effect of neoadjuvant erlotinib hydrochloride on histopathological, molecular, and genetic correlates in patients undergoing radical cystectomy for muscle-invasive bladder cancer. Gene expression of pre-treatment and post-treatment tumor samples were analyzed to define molecular determinants of response or resistance to epidermal growth factor receptor (EGFR) inhibition. Both in vitro and in vivo EGFR-associated signatures were evaluated on pre-treatment bladder tumors. Candidate molecular determinants of sensitivity to EGFR inhibition were characterized and examined for their ability to predict sensitivity to EGFR inhibitors in vitro.
次要结局
- Pathological Complete Response Rate(4 weeks)
- Number of Subjects Experiencing Adverse Events(4 weeks - 2 years following surgery)
- Disease Recurrence and Progression Rates After Cystectomy(2 years)
- Overall Survival Rate(25 months)