Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care Completed 18 and over NCI ECOG-E1Z01 E1Z01, NCT00060398

Objectives

1. 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.
2. Compare the effect of these regimens on increasing hemoglobin levels in these patients.
3. 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.
4. Compare the survival rate of these regimens in these patients.
5. Compare the toxicity profile of these regimens in these patients.
6. Determine the incidence of adrenal suppression in these patients after receiving dexamethasone therapy.

Entry 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

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

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

Expected Enrollment

A total of 282 patients (141 per treatment arm) will be accrued for this study within approximately 3 years.

Outcomes

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

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

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.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Shirley Hwang, RN, MS, Protocol chair		Ph: 973-395-7090

Registry Information
Official Title		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
Trial Start Date		2004-06-01
Trial Completion Date		2006-06-15
Registered in ClinicalTrials.gov		NCT00060398
Date Submitted to PDQ		2003-04-04
Information Last Verified		2006-07-03
NCI Grant/Contract Number		CA21115

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