Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer

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