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| Sponsor: | Eastern Cooperative Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00060398 |
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 III |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Active Control |
| 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 |
| Estimated Enrollment: | 282 |
| Study Start Date: | June 2004 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer
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
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
More than 30 days since prior corticosteroids for hormone-refractory prostate cancer
Radiotherapy
Surgery
Other
Contacts and Locations
Show 140 Study Locations| Study Chair: | Shirley S. Hwang, RN, MS | Veterans Affairs Medical Center - East Orange |
More Information
| Study ID Numbers: | CDR0000301881, ECOG-E1Z01 |
| Study First Received: | May 6, 2003 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00060398 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent prostate cancer anemia fatigue |
|
Anti-Inflammatory Agents Dexamethasone Epoetin Alfa Prostatic Diseases Genital Neoplasms, Male Antineoplastic Agents Hematologic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Urogenital Neoplasms Hormones Signs and Symptoms Neoplasms by Site Therapeutic Uses |
Dexamethasone acetate Fatigue Antineoplastic Agents, Hormonal Hematinics Hematologic Diseases Anemia Gastrointestinal Agents Genital Diseases, Male Glucocorticoids Pharmacologic Actions Neoplasms Autonomic Agents Peripheral Nervous System Agents Prostatic Neoplasms Central Nervous System Agents |