Cancer, Non-Myeloid Malignancies
Conditions
Keywords
darbepoetin alfa, anemia, Amgen, Chemotherapy
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.
Interventions
DRUGrHuEPO
rHuEPO 40,000U QW for 4 weeks. Dose will be increased to 60,000U/week at week 5 if inadequate response through week 12.
DRUGDarbepoetin alfa
4.5 mcg/kg QW for 4 weeks then Q3W starting at week 5 through week 11.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to hematopoietic response during the comparative treatment period | during the comparative treatment period |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Slope of change in hemoglobin after the first month of treatment | baseline to first month of treatment |
| Overall incidence of adverse events, serious adverse events and related adverse events as measured throughout study | throughout study |
| 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 |
| Change in FACT-Fatigue scale score over time during the comparative treatment period | during the comparative treatment period |
Outcome results
None listed