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
18 Years
45 Years
Male
Prostate Cancer
Trial Information
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
OBJECTIVES:
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Normal healthy males judged to be in good medical condition based on history and
physical exam confirming the absence of chronic medical conditions
- Baseline serum lycopene less than 600 nM
PATIENT CHARACTERISTICS:
Age:
- 18 to 45
Performance status:
- Karnofsky 100%
Life expectancy:
- Not specified
Hematopoietic:
- Hematologic function normal
Hepatic:
- Liver function normal
- No hepatic disease
Renal:
- Kidney function normal
- No renal disease
Cardiovascular:
- No hypertension requiring medication
- No cardiovascular disease
- Normal EKG
Other:
- No evidence of a psychiatric disorder
- Must be within 15% of ideal body weight based on standard weight tables
- No history of smoking within the past 3 months
- At least 72 hours since prior alcohol consumption and no history of alcohol abuse
- No history of gastrointestinal malabsorption or any other condition that could affect
drug absorption
- No allergy to tomato based products
- No active malignancy at any site
- No illness that would pose a threat or additional risk (e.g., thyroid disease,
diabetes mellitus)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- At least 14 days since prior prescription drugs
- No concurrent regular prescription medications
- At least 30 days since other prior experimental drugs
- No concurrent participation in any other experimental trial
Type of Study:
Interventional
Study Design:
Primary Purpose: Prevention
Principal Investigator
Keith A. Rodvold
Investigator Role:
Study Chair
Investigator Affiliation:
University of Illinois
Authority:
United States: Federal Government
Study ID:
UIC-H-99-058
NCT ID:
NCT00006078
Start Date:
June 2000
Completion Date:
January 2005
Related Keywords:
- Prostate Cancer
- prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| University of Illinois Medical Center | Chicago, Illinois 60612 |
