Lycopene In Preventing of Prostate Cancer
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of lycopene may be an effective way to prevent prostate cancer.
PURPOSE: Phase I trial to study the effectiveness of lycopene in preventing prostate cancer.
|Study Design:||Primary Purpose: Prevention|
|Official Title:||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|
|Study Start Date:||June 2000|
|Study Completion Date:||January 2005|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006078
|United States, Illinois|
|University of Illinois Medical Center|
|Chicago, Illinois, United States, 60612|
|Study Chair:||Keith A. Rodvold||University of Illinois at Chicago|