|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
University of Illinois National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006078 |
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 I |
| Study Type: | Interventional |
| Study Design: | 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:
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:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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
| 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 |
| ClinicalTrials.gov Identifier: | NCT00006078 History of Changes |
| Health Authority: | United States: Federal Government |
|
prostate cancer |
|
Anticarcinogenic Agents Radiation-Protective Agents Antioxidants Prostatic Diseases Genital Neoplasms, Male Lycopene |
Urogenital Neoplasms Tomato Healthy Genital Diseases, Male Prostatic Neoplasms |
|
Anticarcinogenic Agents Radiation-Protective Agents Antioxidants Genital Neoplasms, Male Prostatic Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Lycopene Physiological Effects of Drugs |
Urogenital Neoplasms Genital Diseases, Male Protective Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Prostatic Neoplasms |