Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT00306267
Status:
TERMINATED
Last Update Posted:
2011-05-18
First Post:
2006-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of PROCRIT (Epoetin Alfa) 80,000 Units (U) Once Every Four Weeks (Q4W) vs. 40,000 U Once Every Two Weeks (Q2W) in Cancer Patients Not Receiving Chemotherapy
Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Organization:
Study Overview
Official Title:
A Pilot Study to Evaluate the Safety and Efficacy of PROCRIT (Epoetin Alfa) 80,000 Units Once Every Four Weeks (Q4W) vs. 40,000 Units Once Every Two Weeks (Q2W) in Cancer Subjects With Non-Chemotherapy Anemia (NCA)
Status:
TERMINATED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study stopped as it would not address important survival concerns raised in other recently conducted clinical studies.
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 assess the safety and effectiveness of PROCRIT (Epoetin alfa) administered by injection subcutaneously (SC, under the skin), at a dose of 80,000 U once every four weeks or 40,000 U once every two in anemic patients with cancer not receiving chemotherapy or radiation therapy.
Detailed Description:
Epoetin alfa is an analogue (has the identical amino acid sequence) of erythropoetin, a hormone secreted by kidneys known to stimulate red blood cell production. Although epoetin alfa has been known to be effective in treatment of anemia associated with cancer chemotherapy, there are no specific formal guidelines on the use of epoetin alfa for the treatment of anemia in cancer patients not receiving chemotherapy or radiation therapy. Several prospective clinical trials investigating the efficacy of epoetin alfa in cancer-associated anemia included groups of patients not receiving chemotherapy where it was demonstrated that the use of epoetin alfa in this population was safe and effective in increasing hemoglobin (Hb) levels and reducing transfusion requirements. The optimal dosing regimen of epoetin alfa in cancer patients not receiving chemotherapy or radiation therapy remains unclear.
This 17-week study is a prospective, randomized, open-label, multi-center study to assess the safety and effectiveness of epoetin alfa in anemic patients with cancer not receiving chemotherapy or radiation therapy. Eligible patients with hemoglobin level \<= 11 g/dL will receive epoetin alfa 40,000 U once every 2 weeks for 15 weeks or 80,000 U once every 4 weeks for 13 weeks. The study hypothesis are that there are no long-term safety concerns of epoetin alfa administered at these two dosing regimens and that both dosing regimens are equally effective in this patient population. Eligible patients with hemoglobin levels \<= 11 g/dL will receive epoetin alfa 40,000 U once every 2 weeks for 15 weeks or 80,000 U once every 4 weeks for 13 weeks.
This 17-week study is a prospective, randomized, open-label, multi-center study to assess the safety and effectiveness of epoetin alfa in anemic patients with cancer not receiving chemotherapy or radiation therapy. Eligible patients with hemoglobin level \<= 11 g/dL will receive epoetin alfa 40,000 U once every 2 weeks for 15 weeks or 80,000 U once every 4 weeks for 13 weeks. The study hypothesis are that there are no long-term safety concerns of epoetin alfa administered at these two dosing regimens and that both dosing regimens are equally effective in this patient population. Eligible patients with hemoglobin levels \<= 11 g/dL will receive epoetin alfa 40,000 U once every 2 weeks for 15 weeks or 80,000 U once every 4 weeks for 13 weeks.
Study Oversight
Has Oversight DMC:
False
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?: