Phase 2 Randomized Study Evaluating the Efficacy of Gemcitabine With or Without Oxaliplatin in Patients With Advanced Urothelial Cancer That Cannot be Treated With Cisplatin-based Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well giving gemcitabine together with oxaliplatin works compared to gemcitabine alone in treating patients with locally advanced or metastatic bladder cancer.
详细描述
OBJECTIVES:
Primary
- Determine the objective response rate in patients with advanced urothelial cancer treated with gemcitabine hydrochloride with vs without oxaliplatin.
Secondary
- Determine the tolerance of these regimens in these patients.
- Determine the overall survival and progression-free survival of patients treated with these regimens.
- Determine the quality of life of patients treated with these regimens.
- Determine the duration of response in patients treated with these regimens.
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
- None
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
Gemcitabine, Oxaliplatine
•Arm II: Patients receive gemcitabine IV over 100 minutes on days 1 and 15 and oxaliplatin IV over 120 minutes on days 2 and 16.
干预措施: gemcitabine hydrochloride (Drug)
Gemcitabine,
•Arm I: Patients receive gemcitabine hydrochloride IV over 120 minutes on days 1, 8, and 15.
干预措施: gemcitabine hydrochloride (Drug)
Gemcitabine, Oxaliplatine
•Arm II: Patients receive gemcitabine IV over 100 minutes on days 1 and 15 and oxaliplatin IV over 120 minutes on days 2 and 16.
干预措施: oxaliplatin (Drug)
结局指标
主要结局
Objective response rate
时间窗: From baseline to the end of treatment, up to 6 months
次要结局
- Adverse events according to Common Terminology Criteria for Adverse Events (CTCAE)(From baseline to the end of treatment, up to 6 months)
- Overall survival(From baseline to the end of treatment, up to 6 months)
- Progression-free survival(From baseline to the end of treatment, up to 6 months)
- Quality of life as assessed by QLQ-C30 and QLQ-LC13(From baseline to the end of treatment, up to 6 months)
- Duration of response(From baseline to the end of treatment, up to 6 months)