Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433576
Status:
COMPLETED
Last Update Posted:
2014-09-15
First Post:
2007-02-08
Brief Title:
Resveratrol in Treating Patients With Colorectal Cancer That Can Be Removed By Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Repeat-Dose Study of Resveratrol in Colorectal Cancer Patients Tolerability Target Tissue Levels and Pharmacodynamics
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 proteinKi67 by immunohistochemistry Blood samples are collected at baseline and during colorectomy for analysis of resveratrol and its metabolites and other pharmacokinetic studies
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 proteinKi67 by immunohistochemistry Blood samples are collected at baseline and during colorectomy for analysis of resveratrol and its metabolites and other pharmacokinetic studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA046592 | NIH | DCP | httpsreporternihgovquickSearchP30CA046592 |
| NCI-2009-00864 | REGISTRY | None | None |
| CDR0000528296 | None | None | None |
| LRI-6930 | None | None | None |
| N01-CN-25025 | None | None | None |
| CCUM-TASK2B | OTHER | None | None |
| N01-CN-25025-4 | OTHER | None | None |