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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

Phase 1
35 Years
75 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

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


- 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

- 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.

Inclusion Criteria


- Elevated prostate-specific antigen (PSA), meeting 1 of the following criteria:

- PSA > 4.0 ng/mL for patients at any age

- PSA > 2.0 ng/mL for patients 35 to 49 years of age

- PSA rise (velocity) of > 0.75 ng/mL over the past year

- Has undergone a prostate biopsy* (following findings of elevated PSA) within the past
180 days that failed to reveal prostate cancer

- Prostate intraepithelial neoplasia allowed NOTE: *At least 4 core biopsies are
considered acceptable


- Karnofsky performance status 80-100%

- Bilirubin ≤ 2.0 mg/dL

- AST and ALT ≤ 2 times upper limit of normal

- Creatinine ≤ 2.0 mg/dL

- WBC ≥ 3,000/mm^3

- Hemoglobin ≥ 11.0 g/dL

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 125,000/mm^3

- No history of gastrointestinal malabsorption or other condition affecting drug

- No history of food allergy to tomato-based products

- No history of any chronic medical condition that, in the judgment of the
investigator, may pose threat or additional risk to the patient (including a current
history of alcohol or drug abuse)

- No active history of cancer or other illnesses that, in the opinion of the
investigator, could represent a threat to patient's life, including congestive heart
failure or uncontrolled hypertension


- No participation in any other experimental trial within the past 4 weeks

- No concurrent chronic use of nonsteroidal anti-inflammatory drugs

- No concurrent participation in another experimental trial

- No concurrent supplements (except multivitamins), including herbal and soy products

Type of Study:


Study Design:

Primary Purpose: Prevention

Outcome Measure:

Toxicity as measured by NCI CTC v2.0

Safety Issue:


Principal Investigator

Keith A. Rodvold

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Illinois


United States: Federal Government

Study ID:




Start Date:

Completion Date:

September 2006

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • Prostatic Neoplasms