A Phase I Dose-finding Study of Metformin in Combination With Concurrent Cisplatin and Radiation in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) of Metformin in Combination With Concurrent Cisplatin and Radiation
研究概览
简要总结
The purpose of this research study is to test the safety of adding metformin to standard of care. The standard of care treatment will be cisplatin once every 3 weeks for 3 treatments and radiation for 7 weeks.
Metformin is a medication that is currently used to treat diabetes. Increasing amounts of metformin will be given to groups of patients already receiving normal treatment for their cancer to see if metformin causes any good effects by killing your cancer or bad effects (side effects).
详细描述
Patients were registered by contacting the University of Cincinnati Clinical Trials Office. Patients must be registered and consent obtained prior to initiation of any protocol therapy.
Treatment was administered on an outpatient basis. Adverse events and potential risks for metformin and cisplatin and radiation were reported.
Patients must have screening labs performed within 2 weeks of start of treatment including a complete blood count, liver function tests, metabolic renal panel including magnesium, vitamin B12 level, lactate, and C-peptide. Renal panel must be verified within 24 hours of cisplatin administration. They must fulfill inclusion criteria.
The recommended starting dose of metformin in diabetic patients is 500mg orally twice a day which can be escalated by 500mg increments weekly as tolerated with the maximum recommended daily dose of 2550mg.
Cisplatin was given either before or after the radiation therapy fraction that is given on the same day. If radiation is held for more than 2 days (for any reason), cisplatin may be held as well until radiation resumes.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Locally advanced squamous cell cancer of the head and neck, stage III or IV disease (T1-2, N2a-3 or T3-4).
- •Measurable disease
- •No prior chemotherapy or radiation for head and neck squamous cell cancer
- •Life expectancy of greater than 3 months.
- •Adequate labs
排除标准
- •Known metastatic disease.
- •Nasopharyngeal carcinoma
- •History of allergic reactions attributed to metformin or other agents used in study.
- •Known diagnosis of diabetes requiring insulin for control.
- •Administration of metformin within last 4 weeks.
研究组 & 干预措施
Metformin with Chemoradiation
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.
干预措施: Metformin (Drug)
Metformin with Chemoradiation
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.
干预措施: Cisplatin (Drug)
Metformin with Chemoradiation
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of Metformin in Combination With Concurrent Cisplatin and Radiation
时间窗: 24 months
Cohorts of patients received escalating doses of metformin (2000 mg, 2550 mg, or 3000 mg divided into daily doses) with a 7-day to 14-day lead-in prior to CRT based on the modified toxicity probability interval design to allow for possible re-escalation after previous de-escalation and to maximize the ability to identify the maximum tolerated dose (MTD). Patients continued to receive metformin for the duration of CRT as tolerated.
次要结局
- Number of Participants Experiencing No-Reoccurrence at 36 Months(36 months)
- Number of Participants With Adverse Events(36 months)
- Progression Free Survival(24 months)
- Overall Survival(24 months)
研究者
Trisha Wise-Draper
Principal Investigator
University of Cincinnati