Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341055
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2006-06-19
Brief Title:
A Study to Evaluate the Hematologic Response Rate the Rate at Which the Hemoglobin Level Rises of PROCRIT Epoetin Alfa Given at a Dose of 80000 Units Once Weekly to Cancer Patients With Anemia Who Are Receiving Chemotherapy
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Pilot Study to Evaluate the Hematologic Response Rate of PROCRIT Epoetin Alfa at 80000 Units Once Weekly in Anemic Cancer Patients Receiving Chemotherapy
Status:
COMPLETED
Status Verified Date:
2010-03
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 evaluate the hematologic response safety and clinical outcomes of PROCRIT administered once a week in anemic cancer patients receiving chemotherapy
Detailed Description:
When comparing the proposed study dose to current literature the initial study dose of 80000 Units administered once per week is equivalent to an individual dose of 1142 Unitskg body weight for a 70 kg patient It is also common in clinical practice for anemic cancer patients to be treated with a dose of PROCRIT Epoetin alfa of 40000 Units weekly This study was an open-label non-randomized pilot study of cancer patients with non-myeloid malignancies with a hemoglobin 11 gdL planned to receive at least 12 weeks of chemotherapy The objective of the study was to evaluate the hematologic response safety and clinical outcomes of PROCRIT Epoetin alfa at 80000 Units given subcutaneously under the skin once weekly in anemic cancer patients receiving chemotherapy If at any time the hemoglobin was 13 gdL PROCRIT Epoetin alfa therapy was held until the hemoglobin was 12 gdL then resumed at 60000 Units once weekly The dose was also reduced if the hemoglobin rose by 13 gdL in a 2 week period
Additionally the incidence of anti-erythropoietin antibodies at baseline and at end of studyearly withdrawal in study patients who have received a minimum of two or more doses of PROCRIT Epoetin alfa over at least a one-month period was evaluated Rarely antibodies to erythropoietin may form in patients who have some types of diseases eg autoimmune diseases rheumatoid arthritis anemia of chronic disease or in response to exposure to erythropoietin products such as Epoetin alfa necessitating discontinuation of the erythropoietin agent and medical treatment that may include blood transfusions Hemoglobin level vital signs blood pressure and occurrence and severity of adverse events was assessed throughout the study PROCRIT Epoetin alfa was given at a dose of 80000 Units subcutaneously under the skin for 12 weeks The PROCRIT Epoetin alfa dose was monitored throughout the study and the dose was withheld or reduced as necessary to maintain hemoglobin level and rate of hemoglobin rise
Additionally the incidence of anti-erythropoietin antibodies at baseline and at end of studyearly withdrawal in study patients who have received a minimum of two or more doses of PROCRIT Epoetin alfa over at least a one-month period was evaluated Rarely antibodies to erythropoietin may form in patients who have some types of diseases eg autoimmune diseases rheumatoid arthritis anemia of chronic disease or in response to exposure to erythropoietin products such as Epoetin alfa necessitating discontinuation of the erythropoietin agent and medical treatment that may include blood transfusions Hemoglobin level vital signs blood pressure and occurrence and severity of adverse events was assessed throughout the study PROCRIT Epoetin alfa was given at a dose of 80000 Units subcutaneously under the skin for 12 weeks The PROCRIT Epoetin alfa dose was monitored throughout the study and the dose was withheld or reduced as necessary to maintain hemoglobin level and rate of hemoglobin rise
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