Lycopene in Preventing Prostate Cancer in Healthy Participants
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
OBJECTIVES:
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Determine the toxicity and safety of lycopene supplementation as chemoprevention for prostate cancer in healthy participants.
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Determine the pharmacokinetics of this agent in these participants.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Toxicity by blood chemistries and patient histories at 4 weeks after treatment []
- Pharmacokinetics by blood lycopene concentrations at 4 weeks after treatment []
Secondary Outcome Measures
- Define dose range by blood lycopene concentrations at 4 weeks after treatment []
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Healthy participants in good medical condition
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No chronic medical conditions
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No regular use of prescription medications
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No evidence of psychiatric disorder
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Non-smoker
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Former smokers allowed provided they have not smoked within the past 3 months
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No history of alcohol abuse
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Serum lycopene concentration < 700 nM
PATIENT CHARACTERISTICS:
Age
- 18 to 45
Performance status
- Karnofsky 100%
Life expectancy
- Not specified
Hematopoietic
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Hemoglobin ≥ 13.0 g/dL
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WBC ≥ 4,000/mm^3
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Platelet count 150,000-400,000/mm^3
Hepatic
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AST and ALT ≤ 75 U/L
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Bilirubin ≤ 2.0 mg/dL
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No liver disease
Renal
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Creatinine ≤ 1.5 mg/dL
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No renal disease
Cardiovascular
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No cardiovascular disease
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No abnormal EKG
Other
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Within 15% of ideal body weight
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No history of gastrointestinal malabsorption or other condition that would preclude drug absorption
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No alcohol consumption within the past 72 hours
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No allergy to tomato-based products
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No history of cancer
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No diabetes mellitus
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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
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At least 4 weeks since prior experimental drugs
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More than 14 days since prior prescription drugs
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No concurrent participation in another experimental trial
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No concurrent prescription drugs
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Illinois at Chicago Cancer Center | Chicago | Illinois | United States | 60612 |
Sponsors and Collaborators
- University of Illinois at Chicago
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Keith A. Rodvold, University of Illinois at Chicago
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UIC-2004-0040
- CDR0000389223