A Randomized Placebo-Controlled Phase Ib/IIa Safety, Tolerability and Efficacy Study of Oral Phenoxodiol in Combination With Docetaxel Versus Docetaxel Alone in Patients With Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Tumor response as assessed by RECIST criteria and clinical examination
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Phenoxodiol may help docetaxel work better by making tumor cells more sensitive to the drug.
PURPOSE: This randomized phase I/II trial is studying the side effects of docetaxel when given together with either phenoxodiol or placebo and to see how well it works in treating patients with recurrent advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.
详细描述
OBJECTIVES:
Primary
- Determine the safety and tolerability of combination therapy comprising phenoxodiol and docetaxel in patients with recurrent or persistent advanced ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer.
Secondary
- Determine the effect of phenoxodiol on the toxicity of docetaxel using a weekly treatment regimen.
- Determine if combination therapy comprising phenoxodiol and docetaxel is more efficacious than docetaxel therapy alone.
- Determine if combination therapy comprising phenoxodiol and docetaxel affects blood levels of either drug.
- Determine phenotypic differences in the tumor cells of "responders" and "non-responders."
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 120 Years（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
Arm I
Patients receive docetaxel IV over 1 hour on days 1, 8, and 15 and oral placebo three times daily on days 1-21.
干预措施: docetaxel (Drug)
Arm I
Patients receive docetaxel IV over 1 hour on days 1, 8, and 15 and oral placebo three times daily on days 1-21.
干预措施: placebo (Other)
Arm II
Patients receive oral phenoxodiol three times daily on days 1-21 and docetaxel IV over 1 hour on days 1, 8, and 15.
干预措施: docetaxel (Drug)
Arm II
Patients receive oral phenoxodiol three times daily on days 1-21 and docetaxel IV over 1 hour on days 1, 8, and 15.
干预措施: idronoxil (Drug)
结局指标
主要结局
Tumor response as assessed by RECIST criteria and clinical examination
Survival (progression-free/recurrence-free interval and overall survival)
Safety
Changes in tumor marker CA125 as assessed by Rustin criteria
次要结局
未报告次要终点