Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Eflornithine in Treating Patients At High Risk of Developing Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Prevention	Closed	35 to 70	NCI	UCIRVINE-97-18 UCIRVINE-U01-CA-81886-01, NCI-P00-0164, NCT00006101

Objectives

1. Compare the levels of polyamines (putrescine, spermidine, and spermine) and progression-related genes in the prostate tissue of patients at high genetic risk for prostate cancer treated with eflornithine (DFMO) vs placebo.
2. Determine the side effects of DFMO and compare them with the biological effect on the prostate gland in these patients.

Entry Criteria

Disease Characteristics:

• Unaffected brother or first-degree cousin of a young (under age 70) prostate cancer proband with a family history (two or more first-degree relatives) of prostate cancer



• No prior non-localized prostate cancer or previously diagnosed premalignant prostate disease

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No concurrent chemotherapy

Endocrine therapy:

• At least 3 months since prior finasteride

Radiotherapy:

• No prior radiotherapy to pelvic area
• No concurrent x-rays

Surgery:

• Not specified

Other:

• At least 3 months since prior chemoprevention agents
• No aspirin or aspirin-containing products within 10 days prior to each study biopsy
• No concurrent anticoagulants

Patient Characteristics:

Age:

• 35 to 70

Performance status:

• SWOG 0-1

  OR

• Karnofsky 70-100%

Life expectancy:

• At least 5 years

Hematopoietic:

• Hematocrit at least 35%
• WBC at least 4,000/mm³ with normal differential
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin less than 2.0 mg/dL
• SGOT or SGPT less than 2 times normal

Renal:

• Creatinine less than 1.5 mg/dL
• Less than 1+ protein, 0-3 casts, and 0-5 WBCs and RBCs in urine

Gastrointestinal:

• No medically mandated special diet that would preclude compliance with study participation
• No documented or symptomatic gastric or duodenal ulcer disease within the past year

Other:

• No severe metabolic disorders or other life-threatening acute or chronic disease
• No other invasive cancer within the past 5 years except nonmelanoma skin cancer
• No predisposition to difficulties with wound healing or repair

Expected Enrollment

A total of 100 patients (50 per arm) will be accrued for this study within 3 years.

Outline

This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to age (35 to 60 vs 61 to 70) and presence of localized cancer (yes vs no).

All patients receive oral placebo daily for 4 weeks. Patients who are compliant and take the placebo 5-7 days each week are randomized to one of two arms.

• Arm I: Patients receive oral placebo daily.



• Arm II: Patients receive high-dose oral eflornithine (DFMO) daily.

Treatment continues for 1 year in the absence of unacceptable toxicity.

Simoneau AR, Gerner EW, Nagle R, et al.: The effect of difluoromethylornithine on decreasing prostate size and polyamines in men: results of a year-long phase IIb randomized placebo-controlled chemoprevention trial. Cancer Epidemiol Biomarkers Prev 17 (2): 292-9, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Anne Simoneau, MD, Protocol chair		Ph: 714-456-3330 Email: asimonea@uci.edu

Registry Information
Official Title		Randomized Placebo-Controlled, Double-Blind Phase IIb Chemoprevention Trial of Difluoromethylornithine in Brothers and First Cousin Males of Familial Prostate Cancer Probands
Trial Start Date		2000-09-01
Registered in ClinicalTrials.gov		NCT00006101
Date Submitted to PDQ		2000-06-28
Information Last Verified		2005-03-02
NCI Grant/Contract Number		P30-CA62203

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