Lycopene In Preventing of Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006078
First received: August 3, 2000
Last updated: June 25, 2013
Last verified: December 2004
  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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2000
Study Completion Date: January 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006078

Locations
United States, Illinois
University of Illinois Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Study Chair: Keith A. Rodvold University of Illinois at Chicago
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006078     History of Changes
Other Study ID Numbers: UIC-H-99-058, CDR0000067915, UIC-N01-CN-85081, NCI-P00-0143
Study First Received: August 3, 2000
Last Updated: June 25, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Lycopene
Anticarcinogenic Agents
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Radiation-Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014