Study Of Epoetin Alfa Vs Epoetin Alfa With Dexamethasone In Hormone Refractory Prostate Cancer Patients: Impact On Fatigue, Anemia, Functional Status And Quality Of Life

Inclusion Criteria

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