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RATIONALE: Epoetin alfa may stimulate red blood cell production and may help improve
cancer-related anemia and fatigue. Steroid therapy with dexamethasone may increase the
effectiveness of epoetin alfa. It is not yet known if epoetin alfa is more effective with or
without dexamethasone in treating anemia-related fatigue in patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying epoetin alfa and dexamethasone to see
how well they work compared to epoetin alfa alone in treating anemia-related fatigue in
patients with prostate cancer that is refractory to treatment with hormone therapy.
Ages:18 and older
DISEASE CHARACTERISTICS: - Histologically confirmed prostate cancer - Hormone-refractory disease as evidenced by progression on bone scan or CT scan with a rising prostate-specific antigen - Prior bilateral orchiectomy OR other primary hormonal therapy (e.g., estrogen therapy or luteinizing hormone-releasing hormone analog [LHRH] and flutamide) with evidence of treatment failure - Concurrent continual LHRH agonist therapy (e.g., depot leuprolide or goserelin) required for patients who have not undergone bilateral orchiectomy - Must have anemia with hemoglobin ≥ 8 g/dL and < 12 g/dL within the past 14 days - Must be iron replete (i.e., ferritin > 50 ng/mL) within the past 30 days - Presence of fatigue with usual fatigue severity ≥ 3 on the 0-10 numerical scale of the Brief Fatigue Inventory within the past 14 days PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-3 Life expectancy - Not specified Hematopoietic - See Disease Characteristics - No disseminated intravascular coagulation - No autoimmune hemolytic anemia Hepatic - AST and ALT ≤ 2 times upper limit of normal - No prior hemochromatosis or iron intolerance Renal - Creatinine < 2.5 mg/dL Cardiovascular - Adequate blood pressure (i.e., systolic blood pressure < 140 mm Hg and diastolic blood pressure < 90 mm Hg) (treated or untreated) - No history of thromboembolic events - No unstable angina - No poorly controlled cardiac disease Other - Fertile patients must use effective contraception - Able to read, understand, and answer questions on the symptom and quality of life study instruments - No ongoing chronic hemorrhage (e.g., gross hematuria due to advanced prostate cancer)* NOTE: *Microscopic hematuria allowed - No acute or subacute illness that may require transfusion - No gastrointestinal bleeding - No active systemic infection - No known or suspected hypersensitivity to human albumin - No known or suspected hypersensitivity to mammalian cell-derived products - No uncontrolled diabetes PRIOR CONCURRENT THERAPY: Biologic therapy - More than 30 days since prior epoetin alfa Chemotherapy - More than 21 days since prior chemotherapy - No more than 2 different types of prior chemotherapy regimens for hormone-refractory prostate cancer Endocrine therapy - See Disease Characteristics - More than 30 days since prior corticosteroids for hormone-refractory prostate cancer - Episodic use of low-dose steroids for other causes is allowed Radiotherapy - More than 21 days since prior radiotherapy - Concurrent radiotherapy allowed Surgery - See Disease Characteristics Other - More than 8 weeks since prior blood transfusion - No concurrent oral or intravenous antibiotics
Sponsor: Eastern Cooperative Oncology Group
Phase: Phase 3
Trial ID: NCT00060398
Not Accepting Healthy Volunteers