Lycopene In Preventing of Prostate Cancer

University of Illinois

Status and phase

Completed

Phase 1

Conditions

Prostate Cancer

Treatments

Dietary Supplement: lycopene

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00006078

UIC-H-99-058

NCI-P00-0143

UIC-N01-CN-85081

CDR0000067915 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Sex

Male

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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: