A Randomized Phase II Trial of Carboplatin and Gemcitabine +/- Vandetanib in First Line Treatment of Advanced Urothelial Cell Cancer in Patients Who Are Not Suitable to Receive Cisplatin
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 21
- 主要终点
- Progression Free Survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether giving carboplatin and gemcitabine hydrochloride is more effective with or without vandetanib as first-line therapy in treating urinary tract cancer.
PURPOSE: This randomized phase II trial is studying giving carboplatin together with gemcitabine hydrochloride and to see how well it works when given with or without vandetanib as first-line therapy in treating patients with locally advanced or metastatic urinary tract cancer.
详细描述
OBJECTIVES:
Primary
- To determine the antitumor activity (as measured by progression-free survival) of carboplatin and gemcitabine hydrochloride with versus without vandetanib as first-line treatment in patients with locally advanced or metastatic urothelial cell cancer who are not suitable to receive cisplatin.
Secondary
- To determine the safety, feasibility, and tolerability of these regimens in these patients.
- To determine the objective response rate.
- To determine the overall survival of patients treated with these regimens
- To assess the change of size of measurable lesions at 9 weeks of study therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 120 Years（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
Placebo
Carboplatin, Gemcitabine and Placebo
干预措施: carboplatin (Drug)
Placebo
Carboplatin, Gemcitabine and Placebo
干预措施: gemcitabine hydrochloride (Drug)
Placebo
Carboplatin, Gemcitabine and Placebo
干预措施: Placebo (Drug)
vandetanib
Carboplatin, Gemcitabine and vandetanib
干预措施: carboplatin (Drug)
vandetanib
Carboplatin, Gemcitabine and vandetanib
干预措施: gemcitabine hydrochloride (Drug)
vandetanib
Carboplatin, Gemcitabine and vandetanib
干预措施: vandetanib (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 1 year
Time to event PFS, follow-up to 1 year
次要结局
- Tolerability and feasibility(1 year)
- Objective response rate as assessed by RECIST criteria(Up to 1 year)
- Overall survival(2 years)
- Change in size of measurable lesions 9 weeks after start of chemotherapy(9 weeks)
- Toxicity during and after treatment as assessed by NCI CTCAE v 4.0(1 year)