A Phase I/II Single-Arm Trial to Evaluate the Combination of Cisplatin and Gemcitabine With the mTOR Inhibitor Temsirolimus for First-Line Treatment of Patients With Advanced Transitional Cell Carcinoma of the Urothelium
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Safety (recommended phase II dose and dose-limiting toxicities) (phase I)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine hydrochloride and cisplatin together with temsirolimus may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of temsirolimus given together with gemcitabine hydrochloride and cisplatin as first-line therapy in treating patients with locally advanced and/or metastatic transitional cell cancer of the urothelium.
详细描述
OBJECTIVES:
Primary
- To determine a safety profile of temsirolimus in combination with cisplatin and gemcitabine hydrochloride, including dose-limiting toxicities (DLTs) and maximum-tolerated dose (MTD) in patients with locally advanced and/or metastatic transitional cell carcinoma of the urothelium. (phase I)
- To determine the recommended dose for the Phase II stage of the trial and subsequent studies. (phase I)
- To assess progression-free survival (PFS) at six months from date of enrollment. (phase II)
Secondary
- To determine the pharmacokinetic profile of temsirolimus in combination with cisplatin and gemcitabine hydrochloride. (phase I)
- To determine tolerability (side-effects) and feasibility (number of participants requiring dose delays or reduction and/or treatment withdrawal). (phase II)
- To determine objective response rate as assessed by RECIST. (phase II)
- To assess PFS of these patients. (phase II)
- To assess overall survival of these patients. (phase II)
- To determine toxicity during and after treatment in these patients. (phase II)
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
- 16 Years 至 120 Years（Child, 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
结局指标
主要结局
Safety (recommended phase II dose and dose-limiting toxicities) (phase I)
Progression-free survival at 6 months (phase I)
次要结局
- Pharmacokinetics (phase I)
- Safety, including tolerability and feasibility (phase II)
- Toxicity during and after treatment according to NCI CTCAE v 3.0 (phase II)
- Overall survival (phase II)
- Progression-free survival (time-to-event) (phase II)
- Objective (radiological) response rate according to RECIST criteria (phase II)