Phase II Evaluation of Intravenous Paclitaxel, Intraperitoneal Cisplatin, Intravenous Liposomal Doxorubicin and Intraperitoneal Paclitaxel in Women With Optimally-Debulked Stage III Epithelial Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 104
- 主要终点
- Progression-free Survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in 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 paclitaxel, cisplatin, and liposomal doxorubicin in treating women who have undergone surgery for stage III ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
详细描述
OBJECTIVES:
- Determine the efficacy of intraperitoneal (IP) cisplatin, IP and IV paclitaxel, and IV doxorubicin HCl liposome, in terms of progression-free survival and overall survival, in patients with optimally debulked stage III ovarian epithelial, fallopian tube, or primary peritoneal cancer.
- Determine the feasibility of and toxic effects associated with this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 3 hours on day 1, intraperitoneal (IP) cisplatin over 30-60 minutes on day 2, IP paclitaxel over 30-60 minutes on day 8, and doxorubicin HCl liposome IV over 1 hour on day 8. Patients not able to tolerate IP infusion receive paclitaxel IV and cisplatin IV on day 1 only. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 2 years and then annually thereafter.
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
- 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
Paclitaxel/cisplatin/Liposomal Doxorubicin
paclitaxel, cisplatin and liposomal doxorubicin
干预措施: cisplatin (Drug)
Paclitaxel/cisplatin/Liposomal Doxorubicin
paclitaxel, cisplatin and liposomal doxorubicin
干预措施: liposomal doxorubicin (Drug)
Paclitaxel/cisplatin/Liposomal Doxorubicin
paclitaxel, cisplatin and liposomal doxorubicin
干预措施: paclitaxel (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: Once a month for 6 months, then every 6 months for up to 2 years, then annually thereafter.
From date of registration to date of progression (as defined per RECIST), symptomatic deterioration or death due to any cause.
Overall Survival
时间窗: Weekly for 6 weeks, then every 6 months for 2 years, then annually thereafter.
from date of registration to date of death due to any cause. Patients last known to be alive wer censored at date of last contact
次要结局
- Adverse Events(Weekly during 6 weeks of protocol treatment)