Phase I/II Trial of Fenretinide/LXS Oral Powder (NSC 374551) Plus Ketoconazole in Recurrent Ovarian Cancer and Primary Peritoneal Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Phase 2: Event Free Survival
研究概览
简要总结
The purpose of this study is to determine the effectiveness of fenretinide (4-HPR/LXS) plus ketoconazole in the treatment of recurrent ovarian cancer or primary peritoneal carcinoma. In addition, researchers would like to determine if the drugs are most effective together or if fenretinide (4-HPR/LXS) is most effective alone.
详细描述
In this study, an initial Phase I component of six patients will be conducted to monitor for potential toxicities as this wil be the initial adult experience of fenretinide (4-HPR) given together with ketoconazole
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
- •Recurrent epithelial ovarian cancer or primary peritoneal carcinoma that can be platinum sensitive or platinum resistant
- •SWOG Performance Status 0-2
- •Previously received a platinum and paclitaxel containing regimen
- •Projected Life Expectancy of at least 3 months
- •Adequate bone marrow function
- •Adequate organ function
- •Must have received at least 1 prior salvage regimen for recurrent ovarian cancer
- •Recovery from acute toxicities from surgery, radiation or chemotherapy
- •At least 3 weeks from last therapy
排除标准
- •Prior fenretinide oral capsule use allowed. If prior IV fenretinide use, must contact study chair for eligibility
- •Second malignancy within last 5 years
- •Use of concomitant antioxidants, such as vitamin C or E
- •Untreated or symptomatic brain metastases
- •History of hypertriglyceride levels > 200 mg/dl; triglyceride levels < 200 and receiving treatment are okay.
- •Use of certain medications is prohibited - contact study coordinator for information
研究组 & 干预措施
Fenretinide/LXS + Ketoconozale
One course is defined as 7 days of Fenretinide/LXS + Ketoconazole followed by 14 days of rest. A course is repeated every 21 days if no evidence of disease progression for six courses.
干预措施: Fenretinide/LXS + Ketoconazole (Drug)
结局指标
主要结局
Phase 2: Event Free Survival
时间窗: From enrollment up to the first date of progressive disease or death from any cause (up to 48 months after last patient entered on treatment)
The objective response rate will be calculated as the percent of evaluable patients whose best response is a CR or PR, and assoicated exact 95% confidence intervals will be calculated. Time to treatment failure, duration of response and survival will be estimated using the product-limit method of Kaplan and Meier.
Phase 1: To determine the systemic toxicity profile of 4-HPR/LXS oral powder + ketoconazole
时间窗: From time of first dose to the last (average 6 months)
Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen.
Phase 2: Progression Free Survival
时间窗: From date of enrollment until date of documented progression or date of death (up to 48 months after last patient enters treatment)
The objective response rate will be calculated as the percent of evaluable patients whose best response is a CR or PR, and assoicated exact 95% confidence intervals will be calculated. Time to treatment failure, duration of response and survival will be estimated using the product-limit method of Kaplan and Meier.
Phase 2: Overall Survival
时间窗: From enrollment up to first date of progressive disease or death from any cause (up to 48 months after last patient entered treatment)
The objective response rate will be calculated as the percent of evaluable patients whose best response is a CR or PR, and assoicated exact 95% confidence intervals will be calculated. Time to treatment failure, duration of response and survival will be estimated using the product-limit method of Kaplan and Meier.
次要结局
- Pharmacokinetics -(up to 48 months after the last subject enrolled)