Clinical trial NCT00093561: Lycopene in Preventing Prostate Cancer in Healthy Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: prostate cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-10-08
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: PREVENTION

Brief summary: RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development or recurrence of cancer. The dietary supplement lycopene may prevent the development of prostate cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of lycopene in preventing prostate cancer in healthy participants.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Toxicity by blood chemistries and patient histories at 4 weeks after treatment
measure: Pharmacokinetics by blood lycopene concentrations at 4 weeks after treatment
Secondary outcomes:
measure: Define dose range by blood lycopene concentrations at 4 weeks after treatment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago Cancer Center
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Keith A. Rodvold
role: PRINCIPAL_INVESTIGATOR
References: