Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060398
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2003-05-06
Brief Title:
Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 gdL vs 101-119 gdL 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
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 gdL vs 101-119 gdL 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ECOG-E1Z01 | None | None | None |