Single Dose Pharmacokinetic Study of Lycopene Delivered in a Well Defined Food-Based Lycopene Delivery System (Tomato Paste-oil Mixture) in Healthy Male Volunteers Between 18 and 45 Years of Age
- Determine any dose limiting toxicities and the maximum tolerated dose of lycopene
administered orally as a food based delivery system in healthy male subjects 18-45
years of age for the chemoprevention of prostate cancer.
- Determine the pharmacokinetics of this regimen in this population.
- Determine the dose range of this regimen to be used in the 3 month multiple dose study,
based on the toxicity, pharmacokinetics and feasibility resulting from the present
study in this population.
OUTLINE: This is a dose-escalation study.
Patients receive a single dose of oral lycopene in a mixture of tomato paste, water, and
olive oil over 15 minutes on day 1. Patients are asked to maintain a diet that contains
negligible carotinoid for 28 days.
Cohorts of 5 patients receive escalating doses of lycopene until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5 patients
experience dose limiting toxicities.
Patients are followed weekly for 4 weeks.
PROJECTED ACCRUAL: A total of 5-25 patients will be accrued for this study.
Primary Purpose: Prevention
Keith A. Rodvold
University of Illinois
United States: Federal Government
|University of Illinois Medical Center||Chicago, Illinois 60612|