Lycopene In Preventing of Prostate Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Dietary Supplement: lycopene |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Prevention |
| 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 |
| Study Start Date: | June 2000 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Illinois | |
| University of Illinois Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| Study Chair: | Keith A. Rodvold | University of Illinois |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00006078 History of Changes |
| Other Study ID Numbers: | CDR0000067915, UIC-H-99-058, UIC-N01-CN-85081, NCI-P00-0143 |
| Study First Received: | August 3, 2000 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Lycopene Antioxidants |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Radiation-Protective Agents Anticarcinogenic Agents Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013