Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210730
Status:
TERMINATED
Last Update Posted:
2011-06-10
First Post:
2005-09-13
Brief Title:
The Duration Study
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
An Open Label Randomized Study To Evaluate The Response Rate Of Epoetin Alfa PROCRIT Versus NoDelayed PROCRIT Treatment In Patients With Cancer And Persistent Chemotherapy-Induced Myelosuppression Anemia
Status:
TERMINATED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was stopped early due to slow enrollment
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 compare the efficacy of epoetin alfa PROCRITÂ administered subcutaneously sc once every week qw vs no epoetin alfa PROCRITÂ treatment in patients with cancer who are anemic
Detailed Description:
The purpose of this study is to evaluate hematologic response in patients receiving epoetin alfa PROCRIT therapy for persistent chemotherapy-induced myelosuppression anemia after completion of chemotherapy administration as compared to patients who do not receive weekly epoetin alfa PROCRIT immediately after cessation of chemotherapy Further the duration of treatment necessary to achieve these endpoints will be studied A NoDelayed epoetin alfa PROCRIT treatment control whereby patients in the control group will receive epoetin alfa PROCRIT if their Hb decreases to 10gdL during the study will be used to establish the frequency and magnitude of changes in clinical end points that may occur when epoetin alfa PROCRIT treatment is not continued or started for patients with residual myelosuppression after chemotherapy administration has ended A 21 randomization will be used to give every patient a greater chance to receive immediate treatment 666 epoetin alfa PROCRIT treatment vs 333 NoDelayed epoetin alfa PROCRIT treatment The study will be powered to show differences between the two groups in hematologic response
In this study the hematologic response is defined as the proportion of patients who are transfusion-free and are able to maintain their mean Hb level at 11 gdL during the study without a Hb drop to 10 gdL andor transfusion
The study hypothesis was that immediate epoetin alfa PROCRIT treatment would be more effective in treatment of anemia than NoDelayed epoetin alfa PROCRIT treatment in patients with cancer and persistent chemotherapy-induced anemia Patients will be randomized 21 to receive epoetin alf or no epoetin treatment The starting dose will be 40000 Units weekly QW or the dose they were on prior to the study 30000-60000 Units QW If the Hb level decreases to 10 gdL PROCRIT will be initiated at a dose of 40000 Units QW
In this study the hematologic response is defined as the proportion of patients who are transfusion-free and are able to maintain their mean Hb level at 11 gdL during the study without a Hb drop to 10 gdL andor transfusion
The study hypothesis was that immediate epoetin alfa PROCRIT treatment would be more effective in treatment of anemia than NoDelayed epoetin alfa PROCRIT treatment in patients with cancer and persistent chemotherapy-induced anemia Patients will be randomized 21 to receive epoetin alf or no epoetin treatment The starting dose will be 40000 Units weekly QW or the dose they were on prior to the study 30000-60000 Units QW If the Hb level decreases to 10 gdL PROCRIT will be initiated at a dose of 40000 Units QW
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