A Randomized Phase II Study of Chemotherapy ± Metformin in Metastatic Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progression-free survival at 6 months
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Metformin hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if combination chemotherapy is more effective with or without metformin hydrochloride in treating patients with metastatic pancreatic cancer.
PURPOSE: This randomized phase II trial is studying giving cisplatin, epirubicin hydrochloride, capecitabine, and gemcitabine hydrochloride together with metformin hydrochloride to see how well it works compared to cisplatin, epirubicin hydrochloride, capecitabine, and gemcitabine hydrochloride alone in treating patients with metastatic pancreatic cancer.
详细描述
OBJECTIVES:
Primary
- To assess the therapeutic activity of chemotherapy comprising cisplatin, epirubicin hydrochloride, capecitabine, and gemcitabine hydrochloride with versus without metformin hydrochloride in terms of 6-month progression-free survival in patients with metastatic pancreatic cancer.
Secondary
- To assess the overall survival of patients treated with this regimen.
- To assess the response rate in patients treated with this regimen.
- To assess the duration of response in patients treated with this regimen.
- To assess the toxicity in patients treated with this regimen.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 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
PEXG regimen + metformin
cisplatin and epirubicin at 30 mg/mq on days 1 and 15, capecitabine at 1250 mg/mq days 1-28, gemcitabine at 800 mg/mq on days 1 and 15, Metformin at 2 g days 1-28
干预措施: capecitabine (Drug)
PEXG regimen + metformin
cisplatin and epirubicin at 30 mg/mq on days 1 and 15, capecitabine at 1250 mg/mq days 1-28, gemcitabine at 800 mg/mq on days 1 and 15, Metformin at 2 g days 1-28
干预措施: cisplatin (Drug)
PEXG regimen + metformin
cisplatin and epirubicin at 30 mg/mq on days 1 and 15, capecitabine at 1250 mg/mq days 1-28, gemcitabine at 800 mg/mq on days 1 and 15, Metformin at 2 g days 1-28
干预措施: epirubicin (Drug)
PEXG regimen + metformin
cisplatin and epirubicin at 30 mg/mq on days 1 and 15, capecitabine at 1250 mg/mq days 1-28, gemcitabine at 800 mg/mq on days 1 and 15, Metformin at 2 g days 1-28
干预措施: gemcitabine (Drug)
PEXG regimen + metformin
cisplatin and epirubicin at 30 mg/mq on days 1 and 15, capecitabine at 1250 mg/mq days 1-28, gemcitabine at 800 mg/mq on days 1 and 15, Metformin at 2 g days 1-28
干预措施: metformin (Drug)
PEXG regimen
cisplatin and epirubicin at 30 mg/mQ on days 1 and 15, capecitabine at 1250 mg/mq days 1-28, gemcitabine at 800 mg/mq on days 1 and 15
干预措施: capecitabine (Drug)
PEXG regimen
cisplatin and epirubicin at 30 mg/mQ on days 1 and 15, capecitabine at 1250 mg/mq days 1-28, gemcitabine at 800 mg/mq on days 1 and 15
干预措施: cisplatin (Drug)
PEXG regimen
cisplatin and epirubicin at 30 mg/mQ on days 1 and 15, capecitabine at 1250 mg/mq days 1-28, gemcitabine at 800 mg/mq on days 1 and 15
干预措施: epirubicin (Drug)
PEXG regimen
cisplatin and epirubicin at 30 mg/mQ on days 1 and 15, capecitabine at 1250 mg/mq days 1-28, gemcitabine at 800 mg/mq on days 1 and 15
干预措施: gemcitabine (Drug)
结局指标
主要结局
Progression-free survival at 6 months
时间窗: every 2 months
CT scan
次要结局
- Toxicity(every 2 weeks)
- Overall survival(every 14 days during therapy; every 3 months thereafter)
- Response rate(every 2 months)