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

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ClinicalTrials.gov Identifier: NCT00433576
Recruitment Status : Completed
First Posted : February 12, 2007
Last Update Posted : September 15, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Drug: resveratrol Other: pharmacological study Other: laboratory biomarker analysis Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Repeat-Dose Study of Resveratrol in Colorectal Cancer Patients: Tolerability, Target Tissue Levels and Pharmacodynamics
Study Start Date : December 2006
Actual Primary Completion Date : November 2008
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.

 Drug: resveratrol
Given orally

Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

Other: laboratory biomarker analysis
Correlative studies


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacodynamics of resveratrol [ Time Frame: Up to 8 days ]
  2. Concentrations of biomarkers [ Time Frame: Up to day 9 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00433576


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Dean Brenner University of Michigan
More Information
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00433576    
Other Study ID Numbers: NCI-2009-00864
NCI-2009-00864 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000528296
LRI-6930
N01-CN-25025
CCUM-TASK2B ( Other Identifier: University of Michigan )
N01-CN-25025-4 ( Other Identifier: DCP )
P30CA046592 ( U.S. NIH Grant/Contract )
First Posted: February 12, 2007    Key Record Dates
Last Update Posted: September 15, 2014
Last Verified: October 2011
Additional relevant MeSH terms:
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Adenocarcinoma
Rectal Neoplasms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action