Treatment for Patients With Non-Myeloid Malignancies Receiving Chemotherapy

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT00111137

Collaborator

(none)

718

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Non-Myeloid Malignancies	Drug: rHuEPO Drug: Darbepoetin alfa	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

718 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2003

Actual Primary Completion Date :

Nov 1, 2003

Actual Study Completion Date :

Apr 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: rHuEPO	Drug: rHuEPO rHuEPO 40,000U QW for 4 weeks. Dose will be increased to 60,000U/week at week 5 if inadequate response through week 12.
Experimental: Darbepoetin alfa	Drug: Darbepoetin alfa 4.5 mcg/kg QW for 4 weeks then Q3W starting at week 5 through week 11.

Arm

Intervention/Treatment

Active Comparator: rHuEPO

Drug: rHuEPO

rHuEPO 40,000U QW for 4 weeks. Dose will be increased to 60,000U/week at week 5 if inadequate response through week 12.

Experimental: Darbepoetin alfa

Drug: Darbepoetin alfa

4.5 mcg/kg QW for 4 weeks then Q3W starting at week 5 through week 11.

Outcome Measures

Primary Outcome Measures

Time to hematopoietic response during the comparative treatment period [during the comparative treatment period]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
Red blood cell (RBC) transfusion within 4 weeks of screening
Known hypersensitivity to any recombinant mammalian-derived product