A Phase II, Open-Label, Non-Randomized, Pilot Study of Paclitaxel, Carboplatin and Oral Metformin for Patients Newly Diagnosed With Stage II-IV Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
Initially, the prospect of metformin as a neoplastic treatment was considered for malignancies of the prostate, colon and pancreas. However, only select clinical studies involving the use of metformin in the treatment of ovarian cancer have documented improved survival rates. Since no first line regimen has demonstrated compelling superiority in the management of advanced stage ovarian carcinoma, the combination of paclitaxel, carboplatin, and metformin is of particular interest given the triplet's prospect for achieving increased synergy without compromising patient tolerability.
详细描述
A phase II, open-label, non-randomized, pilot study assessing the safety, toxicity, and progression free survival of advanced stage ovarian carcinoma patients who underwent treatment with paclitaxel, carboplatin and metformin. An estimated 30 patients will be required for this study.
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
- •Female Gender
- •Age greater than 18 years
- •Advanced stage epithelial ovarian, fallopian tube, or primary peritoneal cancer
- •Adequate bone marrow function
- •ECOG performance score of 2 or greater
- •Patients must be able to swallow oral medication.
排除标准
- •Subjects must NOT be taking metformin or have been on metformin in the past 6 months.
- •Subjects with a diagnosis of epithelial ovarian, fallopian tube or peritoneal cancers of low malignant potential (borderline carcinomas)
- •Subjects with concomitant malignancy or a previous malignancy within the past three years, melanoma skin cancer excepted
研究组 & 干预措施
Paclitaxel, carboplatin and metformin
Drug: Metformin (850 mg) Drug: Carboplatin (AUC 5 or 6) Drug: Paclitaxel (80 mg/m2)
The regimen will be administered as a dose dense schedule.
干预措施: Metformin (Drug)
Paclitaxel, carboplatin and metformin
Drug: Metformin (850 mg) Drug: Carboplatin (AUC 5 or 6) Drug: Paclitaxel (80 mg/m2)
The regimen will be administered as a dose dense schedule.
干预措施: Paclitaxel (Drug)
Paclitaxel, carboplatin and metformin
Drug: Metformin (850 mg) Drug: Carboplatin (AUC 5 or 6) Drug: Paclitaxel (80 mg/m2)
The regimen will be administered as a dose dense schedule.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Progression free survival
时间窗: 5 years
The primary outcome of progression free survival will compare the percentage of those who have either progressed or died at 1 year with those who were at risk for at least 1 year.
次要结局
- Metabolic biomarker evaluation(3 months)