Lycopene In Preventing of Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006078
• Other study ID #: UIC-H-99-058
• Secondary ID: CDR0000067915UIC
• Status: Completed
• Phase: Phase 1
• First received: August 3, 2000
• Last updated: June 25, 2013
• Start date: June 2000
• Est. completion date: January 2005

Study information

• Verified date: December 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• lycopene

Locations

Country	Name	City	State
United States	University of Illinois Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,