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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)

Tracking Information
First Submitted Date  ICMJE February 8, 2007
First Posted Date  ICMJE February 12, 2007
Last Update Posted Date September 15, 2014
Study Start Date  ICMJE December 2006
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
  • Pharmacodynamics of resveratrol [ Time Frame: Up to 8 days ]
  • Concentrations of biomarkers [ Time Frame: Up to day 9 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2007)
Concentration M1G
Change History Complete list of historical versions of study NCT00433576 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Resveratrol in Treating Patients With Colorectal Cancer That Can Be Removed By Surgery
Official Title  ICMJE Phase I Repeat-Dose Study of Resveratrol in Colorectal Cancer Patients: Tolerability, Target Tissue Levels and Pharmacodynamics
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 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Drug: resveratrol
    Given orally
  • Other: pharmacological study
    Correlative studies
    Other Name: pharmacological studies
  • Other: laboratory biomarker analysis
    Correlative studies
Study Arms  ICMJE 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.

Interventions:
  • Drug: resveratrol
  • Other: pharmacological study
  • Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2007)
20
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00433576
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dean Brenner University of Michigan
PRS Account National Cancer Institute (NCI)
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP