Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lycopene In Preventing of Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00006078
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 26, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE August 3, 2000
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date June 26, 2013
Study Start Date  ICMJE June 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lycopene In Preventing of Prostate Cancer
Official Title  ICMJE 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
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Primary Purpose: Prevention
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Dietary Supplement: lycopene
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00006078
Other Study ID Numbers  ICMJE UIC-H-99-058
CDR0000067915 ( Registry Identifier: PDQ (Physician Data Query) )
UIC-N01-CN-85081
NCI-P00-0143
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Illinois at Chicago
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Keith A. Rodvold University of Illinois at Chicago
PRS Account National Cancer Institute (NCI)
Verification Date December 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP