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

Completed · Phase 1

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT00433576

Run by

National Cancer Institute (NCI)

People needed

20

Starts

2006-12-01

Expected to finish

2009-03-01

Last updated by the study team

2014-09-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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