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Clinical Trials/NCT00006078
NCT00006078CompletedPhase 1

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

University of Illinois at Chicago2 sites in 1 countryStarted: June 1, 2000Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Locations
2
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Primary Purpose
Prevention

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
No

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:
  • •Performance status:
  • •Karnofsky 100%
  • •Life expectancy:
  • •Not specified
  • •Hematopoietic:
  • •Hematologic function normal
  • •Liver function normal
  • •No hepatic disease
  • •Kidney function normal
  • •No renal disease
  • •Cardiovascular:
  • •No hypertension requiring medication
  • •No cardiovascular disease
  • •Normal EKG
  • •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
  • •Not specified
  • •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

Exclusion Criteria

  • Not provided

Investigators

Sponsor Class
Other

Study Sites (2)

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