Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00337948
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2006-06-16
Brief Title:
An Efficacy and Safety Study of PROCRIT Epoetin Alfa in Cancer Patients Receiving Chemotherapy Every Week or Every Four Weeks
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
An Open-Labeled Pilot Study to Evaluate the Effects of High Dose PROCRIT Epoetin Alfa in Maintaining Hemoglobin Levels in Anemic Cancer Patients Receiving Chemotherapy on a Weekly or Every Four Week Regimen
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the effectiveness and safety of epoetin alfa at a starting dose of 60000 Units U once every week QW to a target hemoglobin Hb of 12 gdL Initiation Phase followed by a dose of 60000 U once every other week Q2W to maintain a Hb range of 115 to 125 gdL Maintenance Phase in cancer patients receiving chemotherapy
Detailed Description:
Epoetin alfa administered three times weekly 150 Ukg or once weekly 40000 U results in a response rate defined as 2 gdL hemoglobin Hb increase or Hb 12 gdL of approximately 65 of anemic chemotherapy patients and produces a mean hemoglobin rise of 18 gdL Higher weekly dosing may result in a higher response rate and a more timely mean hemoglobin rise while remaining safe Additionally limited data are available to show whether epoetin alfa maintenance therapy can be administered less frequently than weekly and still maintain hemoglobin levels This is an open label multicenter non-randomized study to determine the safety and effectiveness of epoetin alfa given to cancer patients receiving chemotherapy every week or every four weeks
Patients will receive up to 12 injections of epoetin alfa 60000 U once every week QW subcutaneously under the skin for up to 12 weeks Once a patients hemoglobin level Hg has reached a target level of 12 gdL they will begin the Maintenance Phase Patients who qualify for Maintenance Phase will receive up to 6 injections of 60000 U every other week Q2W epoetin alfa under the skin for up to an additional 12 weeks to maintain hemoglobin 115 gdL during chemotherapy administration Doses will be held and adjusted downward if hemoglobin level rises to 13 gdL or if a very rapid hemoglobin response occurs eg an increase of more than 13 gdL in a 2-week period
Safety evaluations include clinical laboratory tests hemoglobin and hematocrit vital sign measurements blood pressure and incidence and severity of adverse events In addition the incidence of anti-erythropoietin antibodies at baseline and study completionearly withdrawal will be evaluated in patients who receive multiple doses of PROCRIT Epoetin alfa Patients will receive up to 12 injections of 60000 U once every week QW epoetin alfa subcutaneously under the skin for up to 12 weeks Once a patients hemoglobin level Hg has reached a target level of 12 gdL they will begin the Maintenance Phase Patients who qualify for Maintenance Phase will receive up to 6 injections of 60000 U every other week Q2W epoetin alfa under the skin for up to an additional 12 weeks to maintain hemoglobin 115 gdL during chemotherapy administration
Patients will receive up to 12 injections of epoetin alfa 60000 U once every week QW subcutaneously under the skin for up to 12 weeks Once a patients hemoglobin level Hg has reached a target level of 12 gdL they will begin the Maintenance Phase Patients who qualify for Maintenance Phase will receive up to 6 injections of 60000 U every other week Q2W epoetin alfa under the skin for up to an additional 12 weeks to maintain hemoglobin 115 gdL during chemotherapy administration Doses will be held and adjusted downward if hemoglobin level rises to 13 gdL or if a very rapid hemoglobin response occurs eg an increase of more than 13 gdL in a 2-week period
Safety evaluations include clinical laboratory tests hemoglobin and hematocrit vital sign measurements blood pressure and incidence and severity of adverse events In addition the incidence of anti-erythropoietin antibodies at baseline and study completionearly withdrawal will be evaluated in patients who receive multiple doses of PROCRIT Epoetin alfa Patients will receive up to 12 injections of 60000 U once every week QW epoetin alfa subcutaneously under the skin for up to 12 weeks Once a patients hemoglobin level Hg has reached a target level of 12 gdL they will begin the Maintenance Phase Patients who qualify for Maintenance Phase will receive up to 6 injections of 60000 U every other week Q2W epoetin alfa under the skin for up to an additional 12 weeks to maintain hemoglobin 115 gdL during chemotherapy administration
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