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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

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Trial Conditions
  • Anemia
  • Fatigue
  • Prostate Cancer
What is the purpose of this trial?

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Male

Eligibility

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

Gender: Male
Steward Physician(s)
  • Shirley S. Hwang, RN, MS
Trial Interventions
Biological
  • epoetin alfa
Drug
  • dexamethasone
Physician Researcher

Investigator Name:

  • Shirley S. Hwang, RN, MS

Other Information

Sponsor: Eastern Cooperative Oncology Group
Phase: Phase 3
Trial ID: NCT00060398
Volunteers:  Not Accepting Healthy Volunteers

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