A Randomized, Open Label Study to Assess Time to Hemoglobin Response of a Front Load Dosing Regimen for Darbepoetin Alfa Compared to a Weekly Dose Regimen for Recombinant Human Erythropoietin in Patients With Non-Myeloid Malignancies Receiving Chemotherapy

Amgen0 sites718 target enrollmentFebruary 2003

ConditionsCancer Non-Myeloid Malignancies

InterventionsrHuEPO Darbepoetin alfa

DrugsrHuEPO Darbepoetin alfa

Overview

Phase: Phase 3
Intervention: rHuEPO
Conditions: Cancer
Sponsor: Amgen
Enrollment: 718
Primary Endpoint: Time to hematopoietic response during the comparative treatment period
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to compare the time to hematopoietic response (hemoglobin correction to 12 g/dL or a greater than or equal to 2 g/dL increase from baseline) for subjects randomized to receive darbepoetin alfa with a front load dosing regimen to those receiving recombinant human erythropoietin (rHuEPO) with a weekly dose regimen during the 12-week comparative treatment period.

Registry

clinicaltrials.gov

Start Date

February 2003

End Date

April 2004

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Amgen

Eligibility Criteria

Inclusion Criteria

•Subjects with non-myeloid malignancies planning to receive cyclic chemotherapy for 8 additional weeks or more
•Anemia (hemoglobin \[hgb\] greater than or equal to 9.0g/dL and less than or equal to 11.0 g/dL) related to cancer and chemotherapy
•Karnofsky performance status of greater than or equal to 50%
•Serum bilirubin less than or equal to 2.5 times the upper limit of normal range and serum creatinine concentration of less than or equal to 2.0 mg/dL

Exclusion Criteria

•Acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes
•Hematologic disorder previously associated with anemia
•Active bleeding
•Iron deficiency
•Received erythropoietic therapy within 14 days prior to randomization
•Unstable cardiac disease
•Known positive human immunodeficiency virus antibody or hepatitis B surface antigen
•Known positive antibody response to any erythropoietic agent
•Currently enrolled in, or has not yet completed at least 30 days since ending other investigational device or drug trial or is receiving investigational agent(s) not approved for any indication
•Pregnant or breast feeding

Arms & Interventions

rHuEPO

Intervention: rHuEPO

Darbepoetin alfa

Intervention: Darbepoetin alfa

Outcomes

Primary Outcomes

Time to hematopoietic response during the comparative treatment period

Time Frame: during the comparative treatment period

Secondary Outcomes

Exploratory analyses for other patient reported outcome scales collected during the study (FACT-Anemia, BSI, EQ-5D, and Patient Satisfaction Questionnaire for Injectable Anemia Treatment)(during the study)
Incidence, if any, of neutralizing antibody formation to study drug(throughout study)
Difference between the average hemoglobin after the first month of treatment compared to the baseline hemoglobin(baseline to first month of treatment)
Time to 2 g/dL increase in hemoglobin during the comparative treatment period(during the comparative treatment period)
Change in FACT-Fatigue scale score over time during the comparative treatment period(during the comparative treatment period)
Overall incidence of adverse events, serious adverse events and related adverse events as measured throughout study(throughout study)
Slope of change in hemoglobin after the first month of treatment(baseline to first month of treatment)
Red blood cell usage during the treatment period and other changes in hemoglobin during the comparative treatment period(during the comparative treatment period)
Changes in hemoglobin during the maintenance period(during the maintenance period)