Clinical trial NCT00111137: Treatment for Patients With Non-Myeloid Malignancies Receiving Chemotherapy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Non-Myeloid Malignancies
Keywords: darbepoetin alfa
anemia
Amgen
Chemotherapy
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-05-18
Enrollment: 718
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Time to hematopoietic response during the comparative treatment period
timeFrame: during the comparative treatment period
Secondary outcomes:
measure: 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)
timeFrame: during the study
measure: Incidence, if any, of neutralizing antibody formation to study drug
timeFrame: throughout study
measure: Difference between the average hemoglobin after the first month of treatment compared to the baseline hemoglobin
timeFrame: baseline to first month of treatment
measure: Time to 2 g/dL increase in hemoglobin during the comparative treatment period
timeFrame: during the comparative treatment period
measure: Change in FACT-Fatigue scale score over time during the comparative treatment period
timeFrame: during the comparative treatment period
measure: Overall incidence of adverse events, serious adverse events and related adverse events as measured throughout study
timeFrame: throughout study
measure: Slope of change in hemoglobin after the first month of treatment
timeFrame: baseline to first month of treatment
measure: Red blood cell usage during the treatment period and other changes in hemoglobin during the comparative treatment period
timeFrame: during the comparative treatment period
measure: Changes in hemoglobin during the maintenance period
timeFrame: during the maintenance period
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: