Phase I Repeat-Dose Study of Resveratrol in Colorectal Cancer Patients: Tolerability, Target Tissue Levels and Pharmacodynamics
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
- Pharmacodynamics of resveratrol
研究概览
简要总结
This phase I trial is studying the side effects and best dose of resveratrol in treating patients with colorectal cancer that can be removed by surgery. Resveratrol may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
详细描述
OBJECTIVES:
I. Determine the relationship between oral dose of resveratrol and the colon mucosal levels of resveratrol and its metabolites in patients with resectable colorectal cancer.
II. Determine the relationship between colon mucosal levels of resveratrol and its metabolites and plasma concentrations of resveratrol and its metabolites in these patients.
III. Determine cyclooxygenase-2 (COX-2) expression in colorectal cancer tissue before and after treatment in these patients.
IV. Determine M_1G concentration in colonic cancer tissue and in circulating white blood cells (WBC) before and after treatment.
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
- •Radiological or clinical evidence of a colorectal malignancy
- •Requires colorectal endoscopy for diagnosis
- •Histologically confirmed adenocarcinoma of the colon or rectum by colorectal endoscopy in stage 1 study
- •Resectable disease
- •Planning to undergo colorectomy
- •WHO performance status 0-2
- •ALT ≤ 2.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •Creatinine ≤ 1.5 mg/dL
- •Hemoglobin ≥ 10 g/dL (transfusion allowed for anemia due to bleeding from the tumor)
- •Suitable for general anesthesia
- •No active peptic ulcer disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No excessive alcohol intake (more than UK recommended limit: 28 or 21 units per week for men or women, respectively)
- •No other cancer that is currently under treatment, clinically detectable, or has been treated within the past 5 years (other than basal cell or squamous cell carcinomas)
- •At least 6 months since prior and no concurrent participation in other invasive or drug studies
- •No radiotherapy or chemotherapy within 4 weeks of endoscopic tissue sampling
- •At least 24 hours since prior and no concurrent nonessential medications or nonsteroidal anti-inflammatory drugs
- •No concurrent resveratrol-containing food and drink (e.g., wine, grapes, peanuts, mulberries, cranberries, blueberries, huckleberries)
- •No concurrent vitamin supplements
- •No concurrent chronic medications, including over-the-counter medications, that may interfere with the pharmacokinetics or pharmacodynamics measured
- •No concurrent medication that could interfere with biomarker assay
- •No concurrent anticoagulants including, warfarin and low molecular weight heparin
- •No concurrent steroids
排除标准
- 未提供
研究组 & 干预措施
Treatment (resveratrol, colorectomy)
STAGE I: Patients undergo an colorectal endoscopy. Patients whose biopsies confirm colorectal adenocarcinoma histology and require surgical resection continue on study stage 2.
STAGE II: Patients receive oral resveratrol on days 1-8. Patients undergo colorectomy on day 9. A tumor biopsy is performed during endoscopy and colorectomy for research purposes.
干预措施: resveratrol (Drug)
Treatment (resveratrol, colorectomy)
STAGE I: Patients undergo an colorectal endoscopy. Patients whose biopsies confirm colorectal adenocarcinoma histology and require surgical resection continue on study stage 2.
STAGE II: Patients receive oral resveratrol on days 1-8. Patients undergo colorectomy on day 9. A tumor biopsy is performed during endoscopy and colorectomy for research purposes.
干预措施: pharmacological study (Other)
Treatment (resveratrol, colorectomy)
STAGE I: Patients undergo an colorectal endoscopy. Patients whose biopsies confirm colorectal adenocarcinoma histology and require surgical resection continue on study stage 2.
STAGE II: Patients receive oral resveratrol on days 1-8. Patients undergo colorectomy on day 9. A tumor biopsy is performed during endoscopy and colorectomy for research purposes.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Pharmacodynamics of resveratrol
时间窗: Up to 8 days
Concentrations of biomarkers
时间窗: Up to day 9
次要结局
未报告次要终点