NCT00433576

Resveratrol in Treating Patients With Colorectal Cancer That Can Be Removed By Surgery

Phase I Repeat-Dose Study of Resveratrol in Colorectal Cancer Patients: Tolerability, Target Tissue Levels and Pharmacodynamics

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Adenocarcinoma of the Colon
• Adenocarcinoma of the Rectum
• Stage I Colon Cancer
• Stage I Rectal Cancer
• Stage II Colon Cancer
• Stage II Rectal Cancer
• Stage III Colon Cancer
• Stage III Rectal Cancer

Interventions

Type	Name	Description
DRUG	resveratrol	Given orally
OTHER	pharmacological study	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2006-12-01
• Primary completion: 2008-11-01
• Completion: 2009-03-01
• First posted: 2007-02-12
• Last updated: 2014-09-15

Locations

1 site across 1 country: United States