Neoadjuvant Eflornithine and Bicalutamide Compared With Eflornithine Alone, Bicalutamide Alone, and No Neoadjuvant Therapy in Treating Patients With Localized Prostate Cancer Undergoing Brachytherapy or Radical Prostatectomy
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: bicalutamide (Drug); eflornithine (Drug); brachytherapy (Procedure); conventional surgery (Procedure)
Phase: Phase 2
Status: Completed
Sponsored by: Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham Official(s) and/or principal investigator(s):
Donald A. Urban, MD, Principal Investigator, Affiliation: Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
Summary
RATIONALE: Drugs used in chemotherapy, such as eflornithine, work in different ways to stop
tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of
prostate cancer cells. Drugs used in hormone therapy, such as bicalutamide, may fight
prostate cancer by stopping the adrenal glands from producing androgens. Combining
eflornithine with bicalutamide may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of neoadjuvant eflornithine
and bicalutamide with that of eflornithine alone, bicalutamide alone, and no neoadjuvant
therapy in treating patients who are undergoing brachytherapy or radical prostatectomy for
localized prostate cancer.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Double-Blind, Placebo Control
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama 35294-3300, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: November 2001
Last updated: May 23, 2008
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