Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416624
Status:
COMPLETED
Last Update Posted:
2017-02-10
First Post:
2006-12-27
Brief Title:
Epoetin Alfa or Darbepoetin Alfa in Treating Patients With Anemia Caused by Chemotherapy
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
RC05CB A Pilot Randomized Comparison of Standard Weekly Epoetin Alfa to Every-3-Week-Epoetin Alfa and Every 3-Week Darbepoetin Alfa
Status:
COMPLETED
Status Verified Date:
2015-09
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 and darbepoetin alfa may cause the body to make more red blood cells They are used to treat anemia caused by chemotherapy in patients with cancer
PURPOSE This randomized clinical trial is studying four different schedules of epoetin alfa or darbepoetin alfa to compare how well they work in treating patients with anemia caused by chemotherapy
PURPOSE This randomized clinical trial is studying four different schedules of epoetin alfa or darbepoetin alfa to compare how well they work in treating patients with anemia caused by chemotherapy
Detailed Description:
OBJECTIVES
Primary
Compare the relative efficacy of four different erythropoietic agent dosing schedules comprising epoetin alfa or darbepoetin alfa in terms of the proportion of patients with chemotherapy-associated anemia who achieve a weekly and overall hematopoietic response
Secondary
Compare the effect of these regimens on the mean hemoglobin increment measured weekly from baseline to 15 weeks in patients with a baseline hemoglobin of less than or equal to 105 gdL
Compare the time required to achieve hemoglobin levels within the goal range 110-120 gdL in patients treated with these regimens
Compare the effect of these regimens on the proportion of patients requiring red blood cell transfusions and on the number of transfusions required
Compare the weekly change in hemoglobin in patients treated with these regimens
Compare the need for dose reduction in patients treated with these regimens
Compare the adverse event profiles of these regimens in these patients
Compare quality of life of patients treated with these regimens
OUTLINE This is a randomized unblinded pilot study Patients are stratified according to severity of anemia mild hemoglobin 95 gdL vs severe hemoglobin 95 gdL platinum-containing regimen yes vs no and tumor type nonmyeloid hematologic malignancy vs solid tumor Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive epoetin alfa subcutaneously SC on day 1 Treatment repeats weekly for up to 15 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive epoetin alfa SC on day 1 at a higher dose than in arm I Treatment repeats every 3 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity
Arm III Patients receive epoetin alfa SC on day 1 at a higher dose than in arm II Treatment repeats every 3 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity
Arm IV Patients receive darbepoetin alfa SC on day 1 Treatment repeats every 3 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity
Hemoglobin levels are monitored throughout the study on a weekly basis and before each drug dose is administered Drug dosing is adjusted eg held reduced resumed at a lower dose as needed to maintain hemoglobin values within the desired ranges
Quality of life is assessed at baseline and at weeks 4 7 10 13 and 16
After completion of study treatment patients are followed at 30 days
PROJECTED ACCRUAL A total of 320 patients will be accrued for this study
Primary
Compare the relative efficacy of four different erythropoietic agent dosing schedules comprising epoetin alfa or darbepoetin alfa in terms of the proportion of patients with chemotherapy-associated anemia who achieve a weekly and overall hematopoietic response
Secondary
Compare the effect of these regimens on the mean hemoglobin increment measured weekly from baseline to 15 weeks in patients with a baseline hemoglobin of less than or equal to 105 gdL
Compare the time required to achieve hemoglobin levels within the goal range 110-120 gdL in patients treated with these regimens
Compare the effect of these regimens on the proportion of patients requiring red blood cell transfusions and on the number of transfusions required
Compare the weekly change in hemoglobin in patients treated with these regimens
Compare the need for dose reduction in patients treated with these regimens
Compare the adverse event profiles of these regimens in these patients
Compare quality of life of patients treated with these regimens
OUTLINE This is a randomized unblinded pilot study Patients are stratified according to severity of anemia mild hemoglobin 95 gdL vs severe hemoglobin 95 gdL platinum-containing regimen yes vs no and tumor type nonmyeloid hematologic malignancy vs solid tumor Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive epoetin alfa subcutaneously SC on day 1 Treatment repeats weekly for up to 15 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive epoetin alfa SC on day 1 at a higher dose than in arm I Treatment repeats every 3 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity
Arm III Patients receive epoetin alfa SC on day 1 at a higher dose than in arm II Treatment repeats every 3 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity
Arm IV Patients receive darbepoetin alfa SC on day 1 Treatment repeats every 3 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity
Hemoglobin levels are monitored throughout the study on a weekly basis and before each drug dose is administered Drug dosing is adjusted eg held reduced resumed at a lower dose as needed to maintain hemoglobin values within the desired ranges
Quality of life is assessed at baseline and at weeks 4 7 10 13 and 16
After completion of study treatment patients are followed at 30 days
PROJECTED ACCRUAL A total of 320 patients will be accrued for this study
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 |
|---|---|---|---|
| EPOANE3015 | OTHER | Centocor protocol | httpsreporternihgovquickSearchP30CA015083 |
| P30CA015083 | NIH | None | None |
| RC05CB | OTHER | None | None |
| 06-002991 | OTHER | None | None |