A Phase II Study of Pioglitazone for Patients With Cancer of the Pancreas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in Serum Adiponectin Level
研究概览
简要总结
This study is being done to determine whether or not addition of the oral medication, pioglitazone to standard chemotherapy, results in improvement of blood tests that measure the body's ability to utilize sugar (glucose and insulin metabolism). In addition the investigators want to determine whether or not treatment with pioglitazone results in (1) improvement in the size of the tumor, (2) weight gain, (3) improved ability to function during the day and (4) quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Signed informed consent
- •Histologically proven adenocarcinoma of the pancreas
- •Radiologically measurable disease
- •ECOG functional status 0-2
排除标准
- •Prior radiation therapy for pancreatic cancer If chemotherapy is planned, new chemotherapy regimen should have started more than 14 days prior to enrollment
- •Surgery or radiation planned within 8 weeks of starting therapy
- •Prior exposure to Thiazolidinedione (TZD) therapy in the past 12 months
- •Hypersensitivity of TZD
- •New York heart association class III/IV heart failure.
- •Known HIV positive
- •Pregnant or lactating women
- •History of, or active bladder cancer
- •Inadequate hepatic function documented within 14 days of enrollment
- •Total bilirubin level > 1.5 x ULN
- •AST and ALT > 2.5 x ULN, unless there are liver metastases in which case AST and ALT or > 5 x ULN
研究组 & 干预措施
Pioglitazone & Chemotherapy in Patients without Diabetes
干预措施: Pioglitazone (Drug)
Pioglitazone & Chemotherapy in Patients with Diabetes
干预措施: Pioglitazone (Drug)
结局指标
主要结局
Change in Serum Adiponectin Level
时间窗: Baseline and 8 weeks of treatment with pioglitazone
We will obtain serum levels of adiponectin at baseline and after 8 weeks of treatment with pioglitazone.
Change in Standard Glucose Tolerance Test
时间窗: Baseline to 120 minutes post glucose bolus
We will perform the area under the oral glucose tolerance test at baseline and after 8 weeks of treatment with pioglitazone.
Glucose to Insulin Ratio
时间窗: Every 4 weeks while receiving treatment, up to 8 weeks
Glucose to insulin ratio will be measured by taking the ratio of fasting level of serum glucose and insulin. We will obtain serum levels of fasting glucose and insulin every four weeks in all patients receiving pioglitazone
次要结局
- Changes in Serum and MRI End Points(Baseline and 8 weeks of treatment with pioglitazone)
- Change in Quality of Life by the FACT-Hep Scale(Baseline and 8 weeks of treatment with pioglitazone)
- Change in Weight(Baseline and every two weeks for 10 weeks, change between baseline and week 10 reported.)
- Number of Patients With Objective Response(8 weeks of treatment with pioglitazone)
- Change in Patients' Performance Status by the Eastern Oncology Cooperative Group (ECOG) Scale of Performance Status(Baseline and 8 weeks of treatment with pioglitazone)
- Change in Body Fast Distribution(Baseline and 8 weeks of treatment with pioglitazone)
- Change in Pancreatic Intratumor Fat(Baseline and 8 weeks of treatment with pioglitazone)
研究者
Muhammad Beg
Associate Professor of Medicine
University of Texas Southwestern Medical Center