Eflornithine in Treating Patients At High Risk of Developing Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2005 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006101
First received: August 3, 2000
Last updated: July 23, 2008
Last verified: March 2005
  Purpose

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of eflornithine may be an effective way to prevent the development of prostate cancer.

PURPOSE: Randomized phase II trial to determine the effectiveness of eflornithine in preventing prostate cancer in patients who are at high risk of developing the disease.


Condition Intervention Phase
Prostate Cancer
Drug: eflornithine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Randomized Placebo-Controlled, Double-Blind Phase IIb Chemoprevention Trial of Difluoromethylornithine in Brothers and First Cousin Males of Familial Prostate Cancer Probands

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 2000
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006101

Locations
United States, California
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, United States, 92868
Sponsors and Collaborators
Chao Family Comprehensive Cancer Center
Investigators
Study Chair: Anne R. Simoneau, MD Chao Family Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00006101     History of Changes
Other Study ID Numbers: CDR0000068110, UCIRVINE-97-18, UCIRVINE-U01-CA-81886-01, NCI-P00-0164
Study First Received: August 3, 2000
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Eflornithine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 17, 2014