Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00270127
Status:
COMPLETED
Last Update Posted:
2011-05-18
First Post:
2005-12-22
Brief Title:
Epoetin Alfa for Anemia in Patients With Cancer Receiving Non-platinum Chemotherapy
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Double-Blind Placebo-Controlled Study to Assess the Effect of Early Intervention andor Treatment With Epoetin Alfa on Anemia in Cancer Patients Receiving Non-Platinum-Containing Chemotherapy
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 effectiveness of epoetin alfa versus placebo in reducing or preventing the need for transfusions in anemic patients with non-myeloid cancer on non-platinum chemotherapy and to investigate quality-of-life benefits associated with the use of epoetin alfa Epoetin alfa is a genetically engineered protein that stimulates red blood cell production
Detailed Description:
Cancer patients often experience anemia due to the disease itself chemotherapy or both Quality of life is also affected due in part to the fatigue associated with anemia Previous studies with epoetin alfa have suggested that achieving a higher hemoglobin level may improve quality of life and help patients live longer This is a randomized double-blind placebo-controlled multicenter study to assess the effect of treatment with epoetin alfa in reducing or preventing anemia and transfusions in patients receiving non-platinum chemotherapy for non-myeloid cancers The study also aims to determine whether changes in erythropoietin and hemoglobin levels after 2 weeks serum ferritin iron levels after 2 weeks and changes in hemoglobin and developing red blood cells after either 2 or 4 weeks predict responsiveness to epoetin alfa There will be 2 treatment groups one group will receive subcutaneous epoetin alfa injections 3 times per week starting at 150 units per kilogram adjusted if needed to a maximum of 300 units per kilogram and the other group will receive an equal volume of matching subcutaneous placebo Treatment is to continue for 12 to 24 weeks 3 to 6 chemotherapy cycles plus 4 weeks post-chemotherapy Patients in the study will be observed a year after the study ends for survival data The primary measure of effectiveness will be determined by the number of patients who are transfused depending on primary tumor type solid or blood and level of hemoglobin above or below 105 grams per deciliter Additional measures of effectiveness include the change in hemoglobin hematocrit and developing red blood cells from the start of the study until study completion and the change in quality of life Safety evaluations incidence and severity of adverse events laboratory tests vital signs and physical examinations will be performed throughout the study The hypothesis of the study is that epoetin alfa will be superior to placebo in reducing the need for transfusions and in improving anemia and quality of life 150 units per kilogram of epoetin alfa or placebo 3 times weekly subcutaneously for 4 weeks then continuing this dose or 300 units per kilogram depending on developing red blood cell counts andor hemoglobin Study duration is 12 to 24 weeks 3 to 6 cycles plus 4 weeks post-chemotherapy
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