Resveratrol in Treating Patients With Colorectal Cancer That Can Be Removed By Surgery
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Purpose
| Condition | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Repeat-Dose Study of Resveratrol in Colorectal Cancer Patients: Tolerability, Target Tissue Levels and Pharmacodynamics |
- Pharmacodynamics of resveratrol [ Time Frame: Up to 8 days ] [ Designated as safety issue: No ]
- Concentrations of biomarkers [ Time Frame: Up to day 9 ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | December 2006 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00433576
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| Principal Investigator: | Dean Brenner | University of Michigan |
More Information
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00433576 History of Changes |
| Other Study ID Numbers: | NCI-2009-00864 NCI-2009-00864 CDR0000528296 LRI-6930 N01CN25025 CCUM-TASK2B N01CN25025-4 P30CA046592 |
| Study First Received: | February 8, 2007 |
| Last Updated: | September 12, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Adenocarcinoma Rectal Neoplasms Colonic 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 |
ClinicalTrials.gov processed this record on September 23, 2016