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Phase I Single Dose Pharmacokinetic Study of the Dietary Supplement Lycopene Delivered in Capsule Form to Healthy Male Volunteers Between 18 and 45 Years of Age


Phase 1
18 Years
45 Years
Not Enrolling
Male
Prostate Cancer

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Trial Information

Phase I Single Dose Pharmacokinetic Study of the Dietary Supplement Lycopene Delivered in Capsule Form to Healthy Male Volunteers Between 18 and 45 Years of Age


OBJECTIVES:

- Determine the toxicity and safety of lycopene supplementation as chemoprevention for
prostate cancer in healthy participants.

- Determine the pharmacokinetics of this agent in these participants.

- Determine the dose range of this agent in these participants.

OUTLINE: This is a dose-escalation study.

Participants ingest a single-dose of oral lycopene over a maximum of 15 minutes on day 1.

Cohorts of 5 participants 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
participants experience dose-limiting toxicity.

Participants are evaluated periodically for 28 days.

PROJECTED ACCRUAL: A total of 25 participants will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Healthy participants in good medical condition

- No chronic medical conditions

- No regular use of prescription medications

- No evidence of psychiatric disorder

- Non-smoker

- Former smokers allowed provided they have not smoked within the past 3
months

- No history of alcohol abuse

- Serum lycopene concentration < 700 nM

PATIENT CHARACTERISTICS:

Age

- 18 to 45

Performance status

- Karnofsky 100%

Life expectancy

- Not specified

Hematopoietic

- Hemoglobin ≥ 13.0 g/dL

- WBC ≥ 4,000/mm^3

- Platelet count 150,000-400,000/mm^3

Hepatic

- AST and ALT ≤ 75 U/L

- Bilirubin ≤ 2.0 mg/dL

- No liver disease

Renal

- Creatinine ≤ 1.5 mg/dL

- No renal disease

Cardiovascular

- No cardiovascular disease

- No abnormal EKG

Other

- Within 15% of ideal body weight

- No history of gastrointestinal malabsorption or other condition that would preclude
drug absorption

- No alcohol consumption within the past 72 hours

- No allergy to tomato-based products

- No history of cancer

- No diabetes mellitus

- No other illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- At least 4 weeks since prior experimental drugs

- More than 14 days since prior prescription drugs

- No concurrent participation in another experimental trial

- No concurrent prescription drugs

Type of Study:

Interventional

Study Design:

Primary Purpose: Prevention

Outcome Measure:

Toxicity by blood chemistries and patient histories at 4 weeks after treatment

Safety Issue:

Yes

Principal Investigator

Keith A. Rodvold

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Illinois

Authority:

United States: Federal Government

Study ID:

UIC-2004-0040

NCT ID:

NCT00093561

Start Date:

August 2004

Completion Date:

February 2006

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • Prostatic Neoplasms

Name

Location

University of Illinois at Chicago Cancer CenterChicago, Illinois  60612