Status:
COMPLETED
Resveratrol in Treating Patients With Colorectal Cancer That Can Be Removed By Surgery
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Colon
Adenocarcinoma of the Rectum
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
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. Determin...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00433576
Start Date
December 1 2006
End Date
March 1 2009
Last Update
September 15 2014
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109