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
18 Years
45 Years
Male
Prostate Cancer
Trial Information
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
OBJECTIVES:
- Determine the toxicity and safety of lycopene supplementation as chemoprevention for
prostate cancer in healthy participants.
- Determine the pharmacokinetics of this agent in these participants.
- Determine the dose range of this agent in these participants.
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.
Inclusion Criteria
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
- Former smokers allowed provided they have not smoked within the past 3
months
- No history of alcohol abuse
- Serum lycopene concentration < 700 nM
PATIENT CHARACTERISTICS:
Age
- 18 to 45
Performance status
- Karnofsky 100%
Life expectancy
- Not specified
Hematopoietic
- Hemoglobin ≥ 13.0 g/dL
- WBC ≥ 4,000/mm^3
- Platelet count 150,000-400,000/mm^3
Hepatic
- AST and ALT ≤ 75 U/L
- Bilirubin ≤ 2.0 mg/dL
- No liver disease
Renal
- Creatinine ≤ 1.5 mg/dL
- No renal disease
Cardiovascular
- No cardiovascular disease
- No abnormal EKG
Other
- Within 15% of ideal body weight
- No history of gastrointestinal malabsorption or other condition that would preclude
drug absorption
- No alcohol consumption within the past 72 hours
- No allergy to tomato-based products
- No history of cancer
- No diabetes mellitus
- No other illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- At least 4 weeks since prior experimental drugs
- More than 14 days since prior prescription drugs
- No concurrent participation in another experimental trial
- No concurrent prescription drugs
Type of Study:
Interventional
Study Design:
Primary Purpose: Prevention
Outcome Measure:
Toxicity by blood chemistries and patient histories at 4 weeks after treatment
Safety Issue:
Yes
Principal Investigator
Keith A. Rodvold
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Illinois
Authority:
United States: Federal Government
Study ID:
UIC-2004-0040
NCT ID:
NCT00093561
Start Date:
August 2004
Completion Date:
February 2006
Related Keywords:
- Prostate Cancer
- prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| University of Illinois at Chicago Cancer Center | Chicago, Illinois 60612 |
