NCT00060398

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 282 (estimated)
• Sponsor: Eastern Cooperative Oncology Group · Network
• Sex: Male
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Anemia
• Fatigue
• Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	epoetin alfa
DRUG	dexamethasone

Timeline

• Start date: 2004-09-29
• Primary completion: 2006-06-01
• First posted: 2003-05-07
• Last updated: 2023-06-15

Locations

140 sites across 1 country: United States

Regulatory

• FDA-regulated drug study