An Efficacy and Safety Study of Epoetin Alfa (PROCRIT®) Initiated at 40,000 Units Every Week Versus 80,000 Units Every Two Weeks in Anemic Patients With Cancer Receiving Chemotherapy. - Full Text View

Purpose

The primary objective of this study is to compare end of study hemoglobin levels between Epoetin alfa (PROCRIT®) at 40,000 units administered subcutaneously once every week and at 80,000 units subcutaneously every two weeks in anemic patients with cancer receiving chemotherapy. The secondary objectives of the study are to assess the Hb response, time to Hb response, transfusion requirements, and safety.

Condition	Intervention	Phase
Anemia	Drug: epoetin alfa	Phase II

MedlinePlus related topics:

Anemia Cancer

ChemIDplus related topics:

Epoetin alfa Erythropoietin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Randomized, Open-Label Study Of Epoetin Alfa (PROCRIT®) Initiated At 40,000 Units Every Week Versus 80,000 Units Every Two Weeks In Anemic Patients With Cancer Receiving Chemotherapy

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

The end of study Hb. The end of study Hb is defined as the patient's final Hb level, taken 2 weeks after the last dose of PROCRIT or at Week 13, whichever comes first.

Secondary Outcome Measures:

Time to Hb increase of 1 g/dL; Proportion of patients achieving a >= 1 g/dL Hb increase by week for Weeks 5-13; Time to Hb increase of 2 g/dL or Hb of >= 12 g/dL; Proportion of patients achieving a >= 2 g/dL Hb increase or Hb of 12 g/dL by end of study.

Estimated Enrollment:	280
Study Start Date:	May 2004
Study Completion Date:	September 2005

Detailed Description:

This is a randomized, open-label, multi-center study to compare end of study hemoglobin level between Epoetin alfa (PROCRIT®) at 40,000 units administered subcutaneously once every week (qw) and at 80,000 units subcutaneously every two weeks (q2w) in approximately 280 anemic patients with cancer receiving chemotherapy. The study hypothesis is that a dosing regimen of PROCRIT 80,000 Units q2w subcutaneously (sc) is non-inferior to a dosing regiman of PROCRIT 40,000 Units qw sc with respect to the change in hemoglobin (Hb) from baseline to Study Week 13 for patients with chemotherapy associated anemia and this respective dosing regimen is generally well-tolerated.

The patients will receive subcutaneous (under the skin) injections of Epoetin alfa (PROCRIT®) at one of the following dosing regimens: 1- Starting dose of 40,000 units sc qw (once every week) OR 2- Starting dose of 80,000 units sc q2w (every two weeks)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed diagnosis of non-myeloid malignancy
Baseline hemoglobin value of <= 11 g/dL unrelated to transfusion
Planned chemotherapy for a minimum of 12 weeks during the study
Life expectancy of >= 6 months
ECOG Performance Status 0-2

Exclusion Criteria:

Diagnosis of a myeloid malignancy or known history of myelodysplasia
Planned non-palliative radiation during the study
Anemia due to factors other than cancer/chemotherapy
Prior treatment with Epoetin alfa or any other erythropoietic agent within the previous three months
History of uncontrolled cardiac arrhythmias or history of pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210834

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Ortho Biotech Products, L.P.

Investigators


Study Director:	Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

A Randomized, Open-Label Study of PROCRIT (Epoetin alfa) Initiated at 40,000 Units Every Week Versus 80,000 Units Every Two Weeks in Anemic Patients with Cancer Receiving Chemotherapy This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications of Results:

Henry DH, Gordan LN, Charu V, Wilhelm FE, Williams D, Xie J, Woodman RC. Randomized, open-label comparison of epoetin alfa extended dosing (80 000 U Q2W) vs weekly dosing (40 000 U QW) in patients with chemotherapy-induced anemia. Curr Med Res Opin. 2006 Jul;22(7):1403-13.

Study ID Numbers:	CR004633
First Received:	September 13, 2005
Last Updated:	March 17, 2008
ClinicalTrials.gov Identifier:	NCT00210834
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

PROCRIT, Erythropoietin, Epoetin alfa, Hemoglobin level

Study placed in the following topic categories:

Epoetin Alfa

Anemia

Additional relevant MeSH terms:

Hematinics

Therapeutic Uses

Hematologic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008

Sponsors and Collaborators:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Ortho Biotech Products, L.P.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00210834