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

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Compare the effect of epoetin alfa with or without dexamethasone on the level of cancer-related fatigue measured by the FACIT fatigue subscale, in patients with hormone-refractory prostate cancer. Compare the effect of these regimens on increasing hemoglobin levels in these patients. Compare the effect of these regimens on palliation of other disease-related symptoms and on functional status and overall quality of life of these patients. Compare the survival rate of these regimens in these patients. Compare the toxicity profile of these regimens in these patients. Determine the incidence of adrenal suppression in these patients after receiving dexamethasone therapy. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to usual fatigue severity on the Brief Fatigue Inventory numerical scale (3-6 vs 7-10) and hemoglobin level (8-10 g/dL vs 10.1-11.9 g/dL). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive epoetin alfa subcutaneously once a week. Arm II: Patients receive epoetin alfa as in arm I and oral dexamethasone once a day. In both arms, treatment continues for 12 weeks in the absence of unacceptable toxicity. Quality of life and fatigue are assessed at baseline and then at 4, 8, and 12 weeks. Patients are followed for 3 years. PROJECTED ACCRUAL: A total of 282 patients (141 per treatment arm) will be accrued for this study within approximately 3 years.

Official Title
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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

Conditions
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Anemia, Fatigue, Prostate Cancer

Intervention / Treatment
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* Biological: epoetin alfa
* Drug: dexamethasone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: epoetin alfa|nan|
|Drug: dexamethasone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue response as measured by the Functional Assessment of Chronic Illness Therapy Fatigue Subscale |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anemia response at 3 months |  |  | 
| Functional level as measured by the Functional Assessment of Cancer Therapy-General Scale and Brief Fatigue Inventory functional interference score monthly |  |  | 
| Symptom distress as measured by the Memorial Symptom Assessment Scale-Short Form and the number of symptoms monthly |  |  | 
| Quality of life as measured by the Functional Assessment of Cancer Therapy-General Scale monthly |  |  | 
| Survival at 6 months |  |  | 
| Adrenal suppression |  |  | 
| Toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent prostate cancer, anemia, fatigue