Phase I Trial of 5-Azacitidine Plus Gemcitabine in Patients With Advanced Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Determine maximum tolerated dose
研究概览
简要总结
The primary objective is to determine the maximum tolerated dose (MTD) of azacitidine and gemcitabine in subjects with previously untreated and unresectable pancreatic cancer. Also to determine the effect of azacitidine therapy on DNA methylation in peripheral blood cells.
详细描述
This is a Phase I single arm study designed for subjects with newly diagnosed, unresectable pancreatic cancer who have received no prior chemotherapy, radiation therapy, or surgery with curative intent for pancreatic cancer.
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
- •Patient must have pathologically confirmed diagnosis of pancreatic adenocarcinoma
- •Must have measurable disease as defined by RECIST. RECIST evaluation must have occurred within 4 weeks prior to study entry
- •Must have newly diagnosed, unresectable disease and have received no prior chemotherapy, radiation therapy or surgery with curative intent for pancreatic cancer
- •Karnofsky performance status of greater than or equal to 70%
- •Other significant medical conditions must be well controlled and stable in the opinion of the investigator for at least 30 days prior to Study Day 1
- •Women of child bearing age must have negative serum pregnancy test prior to treatment
排除标准
- •Known central nervous system tumor involvement
- •Evidence of other active malignancy requiring treatment
- •Clinically significant heart disease
- •Active serious systemic disease, including active bacterial or fungal infection
- •Active viral hepatitis or symptomatic HIV infection. Positive serology alone is not exclusionary
- •Prior surgery with curative intent for pancreatic cancer
- •Prior or current chemotherapy or radiation therapy for pancreatic cancer. Palliative radiation for distant metastases (excluding metastases in the abdominal region) is allowed
- •Breast feeding, pregnant, or likely to become pregnant during the study
- •known or suspected hypersensitivity to azacitidine or mannitol
研究组 & 干预措施
azacitabine
干预措施: Vidaza (Drug)
结局指标
主要结局
Determine maximum tolerated dose
时间窗: 28 days
There will be 5 planned cohorts that will receive the escalating doses of azicitidine and gemcitabine. There will be at least 3 patients in each cohort
Toxicity
时间窗: 28 days
To describe the toxicity associated with the use of this combination regimen
次要结局
- Determine the effect of azacitidine therapy on DNA methylation in peripheral blood cells