Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258440
Status:
TERMINATED
Last Update Posted:
2017-05-09
First Post:
2005-11-23
Brief Title:
Epoetin Alfa in Treating Patients With Anemia Who Are Undergoing Chemotherapy for Cancer
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
A Pilot Trial of Extended Interval Dosing of Epoetin Alfa Procrit for the Treatment of Anemia in Oncology Patients
Status:
TERMINATED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor discontinued funding of the study
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 cause the body to make more red blood cells It is used to treat anemia caused by cancer and chemotherapy It may also help relieve fatigue in patients with anemia
PURPOSE This randomized clinical trial is studying how well epoetin alfa works in treating patients with anemia who are undergoing chemotherapy for cancer
PURPOSE This randomized clinical trial is studying how well epoetin alfa works in treating patients with anemia who are undergoing chemotherapy for cancer
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy in terms of maintenance of target hemoglobin and hematocrit levels of interval dosing with epoetin alfa in treating patients with anemia undergoing chemotherapy for nonhematologic cancer
Secondary
Determine the pharmacokinetics and pharmacodynamics of this drug in these patients
Correlate hemoglobin and hematocrit response with patient age 65 years vs 65 years in patients treated with this drug
Determine quality of life of patients treated with this drug
Determine the adverse effects of this drug in these patients
Determine the change over time of symptom and quality of life variables eg fatigue in patients treated with this drug
OUTLINE This is a partially randomized pilot study Patients are stratified according to age 65 years vs 65 years Patients are assigned to 1 of 2 treatment groups based on participation in the pharmacokinetic PK portion of the study
Group 1 PK study initial therapy Patients are randomized to 1 of 2 treatment arms
Arm I Five patients receive epoetin alfa subcutaneously SC once weekly Treatment continues for 24 weeks in the absence of unacceptable toxicity
Arm II Five patients receive epoetin alfa SC once weekly until hematocrit is 36 OR hemoglobin reaches a value of 12 gdL Patients then proceed to maintenance therapy
Patients in both arms also undergo PK sampling periodically during study treatment
Group 2 non-PK study initial therapy Fifteen patients receive epoetin alfa SC once weekly until hematocrit is 36 OR hemoglobin reaches a value of 12 gdL Patients then proceed to maintenance therapy
Maintenance therapy Patients receive epoetin alfa SC once every other week for up to 24 weeks of total treatment including both initial therapy and maintenance therapy Patients whose blood counts fall below the critical levels are placed on a weekly dosing schedule Patients whose blood counts rise too high discontinue study drug until blood counts are reduced
Quality of life including fatigue is assessed at baseline and then every 4 weeks for 28 weeks
After completion of study therapy patients are followed at 4 weeks
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study
Primary
Determine the efficacy in terms of maintenance of target hemoglobin and hematocrit levels of interval dosing with epoetin alfa in treating patients with anemia undergoing chemotherapy for nonhematologic cancer
Secondary
Determine the pharmacokinetics and pharmacodynamics of this drug in these patients
Correlate hemoglobin and hematocrit response with patient age 65 years vs 65 years in patients treated with this drug
Determine quality of life of patients treated with this drug
Determine the adverse effects of this drug in these patients
Determine the change over time of symptom and quality of life variables eg fatigue in patients treated with this drug
OUTLINE This is a partially randomized pilot study Patients are stratified according to age 65 years vs 65 years Patients are assigned to 1 of 2 treatment groups based on participation in the pharmacokinetic PK portion of the study
Group 1 PK study initial therapy Patients are randomized to 1 of 2 treatment arms
Arm I Five patients receive epoetin alfa subcutaneously SC once weekly Treatment continues for 24 weeks in the absence of unacceptable toxicity
Arm II Five patients receive epoetin alfa SC once weekly until hematocrit is 36 OR hemoglobin reaches a value of 12 gdL Patients then proceed to maintenance therapy
Patients in both arms also undergo PK sampling periodically during study treatment
Group 2 non-PK study initial therapy Fifteen patients receive epoetin alfa SC once weekly until hematocrit is 36 OR hemoglobin reaches a value of 12 gdL Patients then proceed to maintenance therapy
Maintenance therapy Patients receive epoetin alfa SC once every other week for up to 24 weeks of total treatment including both initial therapy and maintenance therapy Patients whose blood counts fall below the critical levels are placed on a weekly dosing schedule Patients whose blood counts rise too high discontinue study drug until blood counts are reduced
Quality of life including fatigue is assessed at baseline and then every 4 weeks for 28 weeks
After completion of study therapy patients are followed at 4 weeks
PROJECTED ACCRUAL A total of 25 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 |
|---|---|---|---|
| ORTHO-ONC-03017-LP | OTHER | OHSU Knight Cancer Institute | None |
| OHSU-ONC-03017-LP | OTHER | None | None |
| OHSU-1616 | OTHER | None | None |
| OHSU-7754 | OTHER | None | None |