Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338416
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 Three 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 Every Three Week Regimen
Status:
COMPLETED
Status Verified Date:
2010-04
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 PROCRIT 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 80000 Units once every three weeks Q3W 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 Hb increase or Hb 12 gdL of approximately 65 of anemic chemotherapy patients and produces a mean hemoglobin Hg rise of 18 gdL Higher weekly dosing of epoetin alfa 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 three weeks
Patients will receive injections of PROCRIT Epoetin alfa 60000 Units U once weekly QW under the skin for up to 12 weeks Initiation Phase to achieve a hemoglobin Hg level of 12 gdL until next full chemotherapy cycle At that time they will begin the Maintenance Phase and will receive up to 4 injections of Epoetin alfa 80000 U every 3 weeks Q3W under the skin for up to an additional 12 weeks 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 adverse events In addition the antibodies that have developed against erythropoietin will be evaluated in patients who receive multiple doses of PROCRIT Epoetin alfa Patients will receive injections of Epoetin alfa 60000 Units U once weekly QW under the skin for up to 12 weeks Initiation Phase to achieve a hemoglobin Hg level of 12 gdL until next full chemotherapy cycle At that time they will begin the Maintenance Phase and will receive up to 4 injections of Epoetin alfa 80000 U every 3 weeks Q3W under the skin for up to an additional 12 weeks
Patients will receive injections of PROCRIT Epoetin alfa 60000 Units U once weekly QW under the skin for up to 12 weeks Initiation Phase to achieve a hemoglobin Hg level of 12 gdL until next full chemotherapy cycle At that time they will begin the Maintenance Phase and will receive up to 4 injections of Epoetin alfa 80000 U every 3 weeks Q3W under the skin for up to an additional 12 weeks 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 adverse events In addition the antibodies that have developed against erythropoietin will be evaluated in patients who receive multiple doses of PROCRIT Epoetin alfa Patients will receive injections of Epoetin alfa 60000 Units U once weekly QW under the skin for up to 12 weeks Initiation Phase to achieve a hemoglobin Hg level of 12 gdL until next full chemotherapy cycle At that time they will begin the Maintenance Phase and will receive up to 4 injections of Epoetin alfa 80000 U every 3 weeks Q3W under the skin for up to an additional 12 weeks
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