Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Lycopene In Preventing of Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Prevention	Completed	18 to 45	NCI	UIC-H-99-058 UIC-N01-CN-85081, NCI-P00-0143, NCT00006078

Objectives

1. 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.
2. Determine the pharmacokinetics of this regimen in this population.
3. 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.

Entry 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

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

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)

Expected Enrollment

A total of 5-25 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

University of Illinois Cancer Center

Keith Rodvold, Protocol chair		Ph: 312-996-3341

Registry Information
Official Title		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
Trial Start Date		2000-06-29
Registered in ClinicalTrials.gov		NCT00006078
Date Submitted to PDQ		2000-05-01
Information Last Verified		2004-12-15

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