Lycopene In Preventing of Prostate Cancer

NCT ID: NCT00006078

Last Updated: 2013-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-06-30
• Study Completion Date: 2005-01-31

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.

Patients are followed weekly for 4 weeks.

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

Conditions

Prostate Cancer

Study Design

• Primary Study Purpose: PREVENTION

Interventions

lycopene

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Principal Investigators

Keith A. Rodvold

Role: STUDY_CHAIR

University of Illinois at Chicago

Locations

University of Illinois Medical Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

CDR0000067915

Identifier Type: REGISTRY

Identifier Source: secondary_id

UIC-N01-CN-85081

Identifier Type: -

Identifier Source: secondary_id

NCI-P00-0143

Identifier Type: -

Identifier Source: secondary_id

UIC-H-99-058

Identifier Type: -

Identifier Source: org_study_id