Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006078
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2000-08-03
Brief Title:
Lycopene In Preventing of Prostate Cancer
Sponsor:
University of Illinois at Chicago
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2004-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-P00-0143 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067915 | REGISTRY | None | None |
| UIC-N01-CN-85081 | None | None | None |