- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006078
Lycopene In Preventing of Prostate Cancer
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
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.
Study Overview
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.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60612
- University of Illinois Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Keith A. Rodvold, University of Illinois at Chicago
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Protective Agents
- Antioxidants
- Anticarcinogenic Agents
- Radiation-Protective Agents
- Lycopene
Other Study ID Numbers
- UIC-H-99-058
- CDR0000067915 (Registry Identifier: PDQ (Physician Data Query))
- UIC-N01-CN-85081
- NCI-P00-0143
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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