A Multi-center Phase II Study of Doxil®/Carboplatin in Patients With Advanced or Recurrent Endometrial Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Response (Complete and Partial)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and carboplatin, 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 phase II trial is studying how well giving doxorubicin hydrochloride liposome together with carboplatin works in treating patients with recurrent, stage III, or stage IV primary endometrial cancer.
详细描述
OBJECTIVES:
Primary
- Estimate the response rate in patients with recurrent or stage III or IV primary endometrial carcinoma treated with doxorubicin hydrochloride liposome and carboplatin.
Secondary
- Determine progression-free survival of patients treated with this regimen.
- Determine overall 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
- Female
- 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
Doxorubicin and carboplatin
Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1
干预措施: carboplatin (Drug)
Doxorubicin and carboplatin
Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1
干预措施: pegylated liposomal doxorubicin hydrochloride (Drug)
结局指标
主要结局
Response (Complete and Partial)
时间窗: Every 28 days
Response Rate
次要结局
未报告次要终点