Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070382
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2003-10-03
Brief Title:
Darbepoetin Alfa Compared With Epoetin Alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Randomized Open-Label Multicenter Study Of Darbepoetin Alfa Administered Once Every Two Weeks Q2W Compared With rHuEPO Administered Once Every Week QW For The Treatment Of Anemia In Subjects With Non-Myeloid Malignancies Receiving Multiple Chemotherapy
Status:
COMPLETED
Status Verified Date:
2012-08
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 Darbepoetin alfa and epoetin alfa may stimulate red blood cell production and treat anemia in patients who are receiving chemotherapy It is not yet known whether darbepoetin alfa is more effective than epoetin alfa in treating patients with anemia
PURPOSE Randomized phase III trial to compare the effectiveness of darbepoetin alfa with that of epoetin alfa in treating anemia in patients who are receiving chemotherapy for cancer
PURPOSE Randomized phase III trial to compare the effectiveness of darbepoetin alfa with that of epoetin alfa in treating anemia in patients who are receiving chemotherapy for cancer
Detailed Description:
OBJECTIVES
Primary
Compare the efficacy of darbepoetin alfa vs epoetin alfa for anemia in patients with non-myeloid malignancies receiving chemotherapy
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to screening hemoglobin concentration less than 100 gdL vs 100-110 gdL and type of concurrent chemotherapy platinum-based vs non-platinum-based Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive darbepoetin alfa subcutaneously SC every other week for 12 weeks ie on weeks 1 3 5 7 9 and 11
Arm II Patients receive epoetin alfa SC once weekly for 12 weeks Patients are followed at 1 and 3 weeks
PROJECTED ACCRUAL A total of 600 patients 300 per treatment arm will be accrued for this study within 6 months
Primary
Compare the efficacy of darbepoetin alfa vs epoetin alfa for anemia in patients with non-myeloid malignancies receiving chemotherapy
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to screening hemoglobin concentration less than 100 gdL vs 100-110 gdL and type of concurrent chemotherapy platinum-based vs non-platinum-based Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive darbepoetin alfa subcutaneously SC every other week for 12 weeks ie on weeks 1 3 5 7 9 and 11
Arm II Patients receive epoetin alfa SC once weekly for 12 weeks Patients are followed at 1 and 3 weeks
PROJECTED ACCRUAL A total of 600 patients 300 per treatment arm will be accrued for this study within 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCLA-0306021 | None | None | None |
| AMGEN-20030125 | None | None | None |