Phase I/II Trial, Dose Finding Combination Chemotherapy With PegLiposomal Doxorubicin (PLD) And Carboplatin In Patients With Gynecologic Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 19
- 主要终点
- DL DLT
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 I/II trial to study the effectiveness of combining liposomal doxorubicin with carboplatin in treating patients who have gynecologic cancer.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of doxorubicin HCl liposome when administered with carboplatin in patients with gynecological tumors.
- Determine the dose-limiting toxicity of this regimen in these patients.
- Determine the kind, frequency, severity, and duration of adverse events in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of doxorubicin HCl liposome.
Patients receive doxorubicin HCl liposome IV over 60 minutes followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 28 days for 6 courses.
Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued and treated at the MTD as above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
PLD
dose finding study of PLD in combination with Carboplatin
干预措施: carboplatin (Drug)
PLD
dose finding study of PLD in combination with Carboplatin
干预措施: pegylated liposomal doxorubicin hydrochloride (Drug)
结局指标
主要结局
DL DLT
时间窗: DLT during first 3 cycles
次要结局
未报告次要终点