Status:
COMPLETED
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
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2003
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00086736
Start Date
November 1 2001
End Date
November 1 2003
Last Update
November 19 2013
Active Locations (1)
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1
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300