Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416325
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2006-12-27
Brief Title:
Lycopene in Preventing Prostate Cancer in Patients Who Are at High Risk of Developing Prostate Cancer
Sponsor:
University of Illinois at Chicago
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Multiple Dose Pharmacokinetic Study of Lycopene Delivered in a Well-Defined Food-Based Lycopene Delivery System Tomato Paste-Oil Mixture in Patients at Increased Risk for Developing Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2006-09
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 is the use of certain drugs or substances to keep cancer from forming growing or coming back The use of lycopene a substance found in tomatoes may keep prostate cancer from forming in patients at high risk of developing prostate cancer
PURPOSE This phase I trial is studying the side effects and best dose of lycopene in preventing prostate cancer in patients who are at high risk of developing prostate cancer
PURPOSE This phase I trial is studying the side effects and best dose of lycopene in preventing prostate cancer in patients who are at high risk of developing prostate cancer
Detailed Description:
OBJECTIVES
Define the toxicity and safety of lycopene administered as a food-based delivery system as a chemoprevention agent in patients who are at a high risk of developing prostate cancer
Define the pharmacokinetics and tissue distribution in patients receiving this regimen
Characterize surrogate endpoint biomarkers SEBs in the peripheral blood buccal mucosa and the prostate itself which will provide evidence of biological activity relevant to a chemoprevention effect
Characterize the oxidative stress state of the individual by studies of DNA oxidation in the prostate and buccal mucosa as well as DNA oxidation and lipid peroxidation within the peripheral blood
Define the effects of lycopene through a food delivery system on prostate histology prostatic intraepithelial neoplasia markers of cellular proliferation PCNA and apoptosis in the prostate
Evaluate the effects of lycopene on the serum levels of total prostate-specific antigen PSA free PSA and PSA density
Provide the basic knowledge in reference to toxicity pharmacokinetics and SEBs needed to proceed to a large phase II or III lycopene study in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive oral lycopene in tomato paste and olive oil once twice or three times daily for 3 months
Cohorts of 6 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 6 patients experience dose-limiting toxicity
Patients undergo buccal scrapings and blood collection periodically during study for pharmacokinetics and biomarker studies
After completion of study treatment patients are followed for 1 month
PROJECTED ACCRUAL A total of 18 patients will be accrued for this study
Define the toxicity and safety of lycopene administered as a food-based delivery system as a chemoprevention agent in patients who are at a high risk of developing prostate cancer
Define the pharmacokinetics and tissue distribution in patients receiving this regimen
Characterize surrogate endpoint biomarkers SEBs in the peripheral blood buccal mucosa and the prostate itself which will provide evidence of biological activity relevant to a chemoprevention effect
Characterize the oxidative stress state of the individual by studies of DNA oxidation in the prostate and buccal mucosa as well as DNA oxidation and lipid peroxidation within the peripheral blood
Define the effects of lycopene through a food delivery system on prostate histology prostatic intraepithelial neoplasia markers of cellular proliferation PCNA and apoptosis in the prostate
Evaluate the effects of lycopene on the serum levels of total prostate-specific antigen PSA free PSA and PSA density
Provide the basic knowledge in reference to toxicity pharmacokinetics and SEBs needed to proceed to a large phase II or III lycopene study in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive oral lycopene in tomato paste and olive oil once twice or three times daily for 3 months
Cohorts of 6 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 6 patients experience dose-limiting toxicity
Patients undergo buccal scrapings and blood collection periodically during study for pharmacokinetics and biomarker studies
After completion of study treatment patients are followed for 1 month
PROJECTED ACCRUAL A total of 18 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 |
|---|---|---|---|
| CDR0000467322 | REGISTRY | PDQ Physician Data Query | None |