A Phase I Study of Weekly Oral Topotecan in Gynecologic Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of topotecan in treating patients with gynecologic cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To establish the maximum tolerated dose (MTD) of oral topotecan hydrochloride in patients with unresectable gynecologic malignancies.
- To determine the safety and tolerability of this drug in these patients.
- To obtain pharmacokinetic data to assess plasma concentrations of this drug when administered at the MTD.
Secondary
- To explore the response in patients treated with this drug.
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
Oral Topotecan
干预措施: topotecan hydrochloride (Drug)
Oral Topotecan
干预措施: pharmacological study (Other)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable toxicity.
Safety and tolerability
时间窗: Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable toxicity.
Plasma concentration of topotecan hydrochloride when administered at the MTD
时间窗: blood sample collection periodically on day 1 of course 1 for pharmacokinetic studies
次要结局
- Response(Treatment repeats every 28 days for up to 6 courses in the absence of disease progression.)
研究者
Steven Waggoner, MD
Principal Investigator
Case Comprehensive Cancer Center