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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00060398
First received: May 6, 2003
Last updated: May 9, 2009
Last verified: July 2006
  Purpose

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.


Condition Intervention Phase
Anemia
Fatigue
Prostate Cancer
Biological: epoetin alfa
Drug: dexamethasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Fatigue response as measured by the Functional Assessment of Chronic Illness Therapy Fatigue Subscale

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 282
Study Start Date: June 2004
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00060398

  Show 140 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Shirley S. Hwang, RN, MS Veterans Affairs Medical Center - East Orange
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00060398     History of Changes
Other Study ID Numbers: CDR0000301881, ECOG-E1Z01
Study First Received: May 6, 2003
Last Updated: May 9, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent prostate cancer
anemia
fatigue

Additional relevant MeSH terms:
Anemia
Fatigue
Prostatic Neoplasms
Hematologic Diseases
Signs and Symptoms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Epoetin Alfa
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 16, 2014