An Open-Labeled Pilot Study of Biomarker Response in Patients With Colorectal Cancer or Endoscopically Non-Resectable Adenomas Following Short-Term Exposure to Metformin Extended Release (ER)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Comparison of Ki-67 in Tumor Samples
研究概览
简要总结
The goal of this clinical research study is to learn more about the possible effects of metformin extended release (ER) in patients with colon cancer or adenomas who are about to have surgery. The safety of this drug will also be studied.
Metformin-ER is commonly used to control blood sugar levels in patients with diabetes. It is also designed to block a protein in tumor cells that is important in tumor growth and blood vessel development. This may cause cell death or reduce the spread of the disease.
详细描述
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups.
- If you are in Group 1, you will receive metformin ER. You will have a 2 in 3 chance of being assigned to Group 1.
- If you are in Group 2, you will receive no treatment. You will have a 1 in 3 chance of being assigned to Group 2.
Study Drug Administration:
If you are in Group 1, You will start taking the drug the day after your colonoscopy (or later if your surgery is scheduled to be more than 30 days after the colonoscopy) and will continue to take it until your scheduled surgery (for up to 30 days). During the first week you will take one tablet of metformin-ER by mouth one time each day with food. From the beginning of the second week until your scheduled surgery, you will take two tablets of metformin-ER by mouth one time each day with food. If you have side effects, your dose may be lowered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age between 18- 75 years
- •Colonic lesion that should be removed surgically:
- •2.a. CRC that is potentially resectable and not requiring neoadjuvant treatment.
- •2.b. Endoscopically non-resectable adenoma.
- •2.c. Familial Adenomatous Polyposis (FAP) patient that requires colectomy or proctocolectomy.
- •Need for perioperative colonoscopy as a part of standard of care evaluation:
- •6.a. CRC or adenoma for which the colorectal surgeon requires a preoperative colonoscopy or sigmoidoscopy for any reason, including but not limited to:
- •6.a.a. No outside colonoscopy
- •6.a.b. No outside pathology
- •6.a.c. Partially obstructing tumor or
- •6.a.d. Otherwise unsatisfactory outside colonoscopy
- •6.a.e. Rectal cancer requiring EUS
- •6.a.f. Second opinion on adenoma regarded as endoscopically non-resectable on outside colonoscopy; or
- •6.b. Patient found on initial MDACC colonoscopy to have CRC or endoscopically non-resectable adenoma, most commonly patients undergoing average or high risk (familial, history of adenoma) screening colonoscopy.
- •Ability to give informed consent.
- •Diabetic patients are eligible but they may be excluded if they are taking Metformin, insulin or sulfonylureas.
排除标准
- •Patients with renal insufficiency defined as serum creatinine >= 1.4 mg/dl for females and >= 1.5 mg/dl for males
- •Pregnant or nursing women
- •A malignancy currently under active therapy
- •Unstable angina
- •Uncontrolled ischemic cardiac disease or symptomatic congestive heart failure (e.g. Class III or IV New York Heart Association's Functional Classification)
- •Current usage of Metformin
- •Current usage of insulin, sulfonylureas
- •History of lactic acidosis
- •Chronic liver disease or cirrhosis
- •Inability to give informed consent
- •Other investigational drugs within the past one year or concurrently
- •Known hypersensitivity or intolerance to Metformin
研究组 & 干预措施
Metformin + Colon Surgery
Patients randomized to Metformin-ER 500 mg once daily for one week and then escalation to 1000 mg/day for the duration of the trial. The duration of the trial will be from the preoperative endoscopy till the surgery, and should be not less than 10 days and not more than 30 days.
干预措施: Metformin ER (Drug)
结局指标
主要结局
Comparison of Ki-67 in Tumor Samples
时间窗: 2 weeks
Primary outcome measure is change in the percentage of Ki67-positive-staining cells between the baseline colonoscopy and surgery in the colon rectal cancer/non-resectable adenoma samples.
次要结局
未报告次要终点