Resveratrol in Treating Patients With Colorectal Cancer That Can Be Removed By Surgery - Full Text View

Sponsors and Collaborators:	University of Michigan Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00433576

Purpose

RATIONALE: Resveratrol may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: 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.

Condition	Intervention	Phase
Colorectal Cancer	Drug: resveratrol Other: immunohistochemistry staining method Other: immunologic technique Other: laboratory biomarker analysis Other: pharmacological study Procedure: biopsy Procedure: endoscopic biopsy Procedure: neoadjuvant therapy	Phase I

MedlinePlus related topics: Cancer Colorectal Cancer Surgery

Drug Information available for: Resveratrol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label
Official Title:	Phase I Repeat-Dose Study of Resveratrol in Colorectal Cancer Patients: Tolerability, Target Tissue Levels and Pharmacodynamics

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Concentration of M1G [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	December 2006

Detailed Description:

OBJECTIVES:

Determine the relationship between oral dose of resveratrol and the colon mucosal levels of resveratrol and its metabolites in patients with resectable colorectal cancer.
Determine the relationship between colon mucosal levels of resveratrol and its metabolites and plasma concentrations of resveratrol and its metabolites in these patients.
Determine cyclooxygenase-2 (COX-2) expression in colorectal cancer tissue before and after treatment in these patients.
Determine M_1G concentration in colonic cancer tissue and in circulating white blood cells (WBC) before and after treatment.
Correlate M_1G concentration in colorectal cancer tissue with M_1G concentration in circulating WBC.
Assess the Ki67 labeling index in normal and malignant tissues in at least 10 fields per section.
Correlate COX-2 expression in colorectal cancer tissue with COX-2 expression in circulating WBCs.
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 1: Patients undergo an colorectal endoscopy. Patients whose biopsies confirm colorectal adenocarcinoma histology and require surgical resection continue on study stage 2.
Stage 2: 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.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Stage 1:
- Radiological or clinical evidence of a colorectal malignancy
- Requires colorectal endoscopy for diagnosis
Stage 2:
- Histologically confirmed adenocarcinoma of the colon or rectum by colorectal endoscopy in stage 1 study
  - Resectable disease
- Planning to undergo colorectomy

PATIENT CHARACTERISTICS:

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) NOTE: *Stage 2 requirements

PRIOR CONCURRENT THERAPY:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00433576

Locations

United States, Michigan
University of Michigan Comprehensive Cancer Center	Recruiting
Ann Arbor, Michigan, United States, 48109-0942
Contact: Clinical Trials Office - University of Michigan Comprehensive 800-865-1125
United Kingdom, England
Leicester Royal Infirmary	Recruiting
Leicester, England, United Kingdom, LE2 7LX
Contact: Andreas J. Gescher, PhD 44-0116-223-1859 ag15@le.ac.uk

Sponsors and Collaborators

University of Michigan Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Dean E. Brenner, MD

University of Michigan Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000528296, CCUM-TASK2B, LRI-6930
Study First Received:	February 8, 2007
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00433576 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the colon
stage I colon cancer
stage II colon cancer
adenocarcinoma of the rectum

stage I rectal cancer
stage II rectal cancer
stage III colon cancer
stage III rectal cancer

Study placed in the following topic categories:

Anti-Inflammatory Agents
Anticarcinogenic Agents
Antioxidants
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Rectal Neoplasm
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Resveratrol

Digestive System Diseases
Rectal Cancer
Analgesics, Non-Narcotic
Gastrointestinal Neoplasms
Anti-Inflammatory Agents, Non-Steroidal
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Colorectal Neoplasms

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anticarcinogenic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Colonic Diseases
Physiological Effects of Drugs
Hematologic Agents
Rectal Diseases
Resveratrol
Neoplasms by Site
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal

Analgesics
Digestive System Neoplasms
Antimutagenic Agents
Enzyme Inhibitors
Intestinal Diseases
Protective Agents
Intestinal Neoplasms
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Analgesics, Non-Narcotic
Gastrointestinal Neoplasms
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 06, 2009