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Phase I Repeat-Dose Study of Resveratrol in Colorectal Cancer Patients: Tolerability, Target Tissue Levels and Pharmacodynamics
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.
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. V. Correlate M\_1G concentration in colorectal cancer tissue with M\_1G concentration in circulating WBC. VI. Assess the Ki67 labeling index in normal and malignant tissues in at least 10 fields per section. VII. Correlate COX-2 expression in colorectal cancer tissue with COX-2 expression in circulating WBCs. VIII. Assess the toxicity profile of this drug. OUTLINE: This is a two-stage nonrandomized, open-label study. Patients are assigned to 1 of 2 dose levels in stage 2. 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. Two biomarkers of the potential activity of resveratrol are measured in nonmalignant and malignant colorectal tissue biopsy samples: levels of M\_1G adducts by immunoslot blot analysis and levels of cyclooxygenase-2 protein/Ki67 by immunohistochemistry. Blood samples are collected at baseline and during colorectomy for analysis of resveratrol and its metabolites and other pharmacokinetic studies.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Michigan
Ann Arbor, Michigan, United States
Start Date
December 1, 2006
Primary Completion Date
November 1, 2008
Completion Date
March 1, 2009
Last Updated
September 15, 2014
20
ACTUAL participants
resveratrol
DRUG
pharmacological study
OTHER
laboratory biomarker analysis
OTHER
Lead Sponsor
National Cancer Institute (NCI)
NCT04668872
NCT07129512
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT02232152