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Randomized Placebo-Controlled, Double-Blind Phase IIb Chemoprevention Trial of Difluoromethylornithine in Brothers and First Cousin Males of Familial Prostate Cancer Probands


Phase 2
35 Years
70 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Randomized Placebo-Controlled, Double-Blind Phase IIb Chemoprevention Trial of Difluoromethylornithine in Brothers and First Cousin Males of Familial Prostate Cancer Probands


OBJECTIVES:

- 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.

- Determine the side effects of DFMO and compare them with the biological effect on the
prostate gland in these patients.

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.

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

Inclusion 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

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/mm^3 with normal differential

- Platelet count at least 100,000/mm^3

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

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Principal Investigator

Anne R. Simoneau, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Chao Family Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068110

NCT ID:

NCT00006101

Start Date:

September 2000

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • Prostatic Neoplasms

Name

Location

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer CenterOrange, California  92868