Phase I Single Dose Pharmacokinetic Study of the Dietary Supplement Lycopene Delivered in Capsule Form to Healthy Male Volunteers Between 18 and 45 Years of Age
Phase I Single Dose Pharmacokinetic Study of the Dietary Supplement Lycopene Delivered in Capsule Form to Healthy Male Volunteers Between 18 and 45 Years of Age
RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development or recurrence of cancer. The dietary supplement lycopene may prevent the development of prostate cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of lycopene in preventing prostate cancer in healthy participants.
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Participants ingest a single-dose of oral lycopene over a maximum of 15 minutes on day 1.
Cohorts of 5 participants 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 participants experience dose-limiting toxicity.
Participants are evaluated periodically for 28 days.
PROJECTED ACCRUAL: A total of 25 participants will be accrued for this study.
DISEASE CHARACTERISTICS:
Healthy participants in good medical condition
No chronic medical conditions
No regular use of prescription medications
No evidence of psychiatric disorder
Non-smoker
No history of alcohol abuse
Serum lycopene concentration < 700 nM
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other