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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


Phase 1
18 Years
45 Years
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


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.

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:

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Prevention

Principal Investigator

Keith A. Rodvold

Investigator Role:

Study Chair

Investigator Affiliation:

University of Illinois

Authority:

United States: Federal Government

Study ID:

UIC-H-99-058

NCT ID:

NCT00006078

Start Date:

June 2000

Completion Date:

January 2005

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • Prostatic Neoplasms

Name

Location

University of Illinois Medical CenterChicago, Illinois  60612