A Phase II Study Of Capecitabine Plus Gemcitabine For Metastatic Renal Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 50
- 主要终点
- Response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining capecitabine with gemcitabine in treating patients who have metastatic kidney cancer.
详细描述
OBJECTIVES:
- Determine the objective response rate in patients with metastatic renal cell carcinoma treated with gemcitabine and capecitabine.
- Determine the duration of overall and progression-free survival of patients treated with this regimen.
- Determine the toxicity of this regimen 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
Gemcitabine + capecitabine
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive at least 2 additional courses beyond CR.
Patients are followed every 3 months for 1 year and then every 6 months for 1 year.
干预措施: capecitabine (Drug)
Gemcitabine + capecitabine
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive at least 2 additional courses beyond CR.
Patients are followed every 3 months for 1 year and then every 6 months for 1 year.
干预措施: gemcitabine hydrochloride (Drug)
结局指标
主要结局
Response rate
时间窗: Up to 2 years
次要结局
- Overall survival(Up to 2 years)
- Progression-free survival(Up to 2 years)