Phase II Trial Of Pemetrexed Disodium And Gemcitabine In Advanced Urothelial Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 121
- 主要终点
- Response as measured by RECIST criteria
研究概览
简要总结
RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining pemetrexed disodium with gemcitabine may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining pemetrexed disodium with gemcitabine in treating patients who have advanced cancer of the urothelium.
详细描述
OBJECTIVES:
Primary
- Determine the response rate in patients with previously untreated advanced cancer of the urothelium treated with pemetrexed disodium and gemcitabine.
- Determine the toxicity of this regimen in these patients.
Secondary
- Determine the overall survival and time to progression in patients treated with this regimen.
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 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
Pemetrexed Disodium and Gemcitabine
Pemetrexed disodium 500 mg/m2 followed by gemcitabine 1000 mg/m2 on day 1 and gemcitabine 1000 mg/m2 on day 8 of a 21-day cycle for a maximum of 6 cycles
干预措施: gemcitabine hydrochloride (Drug)
Pemetrexed Disodium and Gemcitabine
Pemetrexed disodium 500 mg/m2 followed by gemcitabine 1000 mg/m2 on day 1 and gemcitabine 1000 mg/m2 on day 8 of a 21-day cycle for a maximum of 6 cycles
干预措施: pemetrexed disodium (Drug)
结局指标
主要结局
Response as measured by RECIST criteria
时间窗: Assessed every 6 weeks
次要结局
- Time to disease progression(Assessed every 6 weeks)
- Overall survival(Assessed every 3 months for 2 years, then every 6 months for 3 years)