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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

Phase 3
18 Years
Not Enrolling
Anemia, Fatigue, Prostate Cancer

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Trial Information

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


- 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.

Inclusion Criteria


- 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



- 18 and over

Performance status

- ECOG 0-3

Life expectancy

- Not specified


- See Disease Characteristics

- No disseminated intravascular coagulation

- No autoimmune hemolytic anemia


- AST and ALT ≤ 2 times upper limit of normal

- No prior hemochromatosis or iron intolerance


- Creatinine < 2.5 mg/dL


- 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


- 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


Biologic therapy

- More than 30 days since prior epoetin alfa


- 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


- More than 21 days since prior radiotherapy

- Concurrent radiotherapy allowed


- See Disease Characteristics


- More than 8 weeks since prior blood transfusion

- No concurrent oral or intravenous antibiotics

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Outcome Measure:

Fatigue response as measured by the Functional Assessment of Chronic Illness Therapy Fatigue Subscale

Principal Investigator

Shirley S. Hwang, RN, MS

Investigator Role:

Study Chair

Investigator Affiliation:

Veterans Affairs Medical Center - East Orange


United States: Federal Government

Study ID:




Start Date:

June 2004

Completion Date:

Related Keywords:

  • Anemia
  • Fatigue
  • Prostate Cancer
  • recurrent prostate cancer
  • anemia
  • fatigue
  • Anemia
  • Fatigue
  • Prostatic Neoplasms



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