Prostate Cancer Clinical Trial
Lycopene In Preventing of Prostate Cancer
Summary
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.
Eligibility 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
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There is 1 Location for this study
Chicago Illinois, 60612, United States
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