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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Resveratrol

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