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A Randomized, Placebo-Controlled Phase IIb Clinical Trial of 2-Difluoromethylornithine (DFMO) Versus Bicalutamide (CASODEX) Alone and in Combination in Patients With Prostate Cancer in the Period Prior to Radical Prostatectomy or Brachytherapy: Modulation of Tissue and Molecular Biomarkers in Human Prostate Tissue Serum


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Randomized, Placebo-Controlled Phase IIb Clinical Trial of 2-Difluoromethylornithine (DFMO) Versus Bicalutamide (CASODEX) Alone and in Combination in Patients With Prostate Cancer in the Period Prior to Radical Prostatectomy or Brachytherapy: Modulation of Tissue and Molecular Biomarkers in Human Prostate Tissue Serum


OBJECTIVES:

- Compare levels of polyamine spermine, polyamine putrescine, and spermidine in patients
with localized prostate cancer undergoing brachytherapy or radical prostatectomy and
treated with neoadjuvant eflornithine and bicalutamide vs eflornithine alone vs
bicalutamide alone vs no neoadjuvant therapy.

- Compare the expression of surrogate biomarkers (i.e., serum prostate-specific antigen,
tissue levels of proliferating cell nuclear antigen, Ki67, and TGF-alpha, apoptosis
assays [ICH-PARP and TUNEL], and cytomorphometric indices) in patients treated with
these regimens.

- Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
stratified according to Gleason score (< 7 vs ≥ 7). Patients are randomized to 1 of 4
treatment arms.

- Arm I: Patients receive oral eflornithine and oral bicalutamide once daily.

- Arm II: Patients receive oral eflornithine and oral bicalutamide placebo once daily.

- Arm III: Patients receive oral eflornithine placebo and oral bicalutamide once daily.

- Arm IV: Patients receive oral eflornithine placebo and oral bicalutamide placebo once
daily.

In all arms, treatment continues for 28 days in the absence of unacceptable toxicity.
Patients then undergo either prostatectomy or brachytherapy, as determined by the patient,
on day 29.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 44 patients (11 per treatment arm) will be accrued for this
study within 11 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed prostate cancer

- Localized disease

- Paraffin blocks from diagnostic biopsies available

- Planning to undergo brachytherapy or prostatectomy

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-3

Life expectancy

- Not specified

Hematopoietic

- Hemoglobin ≥ 10.0 g/dL

- WBC ≥ 3,500/mm^3

- Platelet count ≥ 125,000/mm^3

Hepatic

- Bilirubin ≤ 2.0 mg/dL

- SGOT and SGPT ≤ 2 times normal

- No history of liver disease (e.g., hepatitis, cirrhosis, or jaundice)

Renal

- Creatinine ≤ 2.0 mg/dL

Cardiovascular

- No symptomatic coronary artery disease

- No uncontrolled hypertension

- No acute myocardial infarction within the past year

Other

- Fertile patients must use effective contraception

- No more than 10 decibels baseline hearing loss at any frequency by full bilateral
audiometry within the past month

- No hypersensitivity to eflornithine or bicalutamide

- No other prior or active malignancy except nonmelanoma skin cancer or other cancer
curatively treated at least 5 years ago with no evidence of recurrent or residual
disease

- No concurrent acute or chronic medical or psychiatric condition that would preclude
study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent immunotherapy

Chemotherapy

- No other concurrent chemotherapy

Endocrine therapy

- More than 1 year since prior antiandrogen, luteinizing hormone-releasing hormone
(LHRH) agonist, bicalutamide, finasteride, or diethylstilbestrol

- No other concurrent antiandrogen, LHRH agonist, finasteride, or diethylstilbestrol

Radiotherapy

- See Disease Characteristics

- No other concurrent radiotherapy

Surgery

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Donald A. Urban, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Federal Government

Study ID:

CDR0000353198

NCT ID:

NCT00086736

Start Date:

November 2001

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • Prostatic Neoplasms

Name

Location

University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300