Treatment for Patients With Non-Myeloid Malignancies Receiving Chemotherapy

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00111137
First received: May 17, 2005
Last updated: February 20, 2008
Last verified: February 2008
  Purpose

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 Intervention Phase
Cancer
Non-Myeloid Malignancies
Drug: rHuEPO
Drug: Darbepoetin alfa
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Time to hematopoietic response during the comparative treatment period [ Time Frame: during the comparative treatment period ] [ Designated as safety issue: No ]

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) [ Time Frame: during the study ] [ Designated as safety issue: No ]
  • Incidence, if any, of neutralizing antibody formation to study drug [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Difference between the average hemoglobin after the first month of treatment compared to the baseline hemoglobin [ Time Frame: baseline to first month of treatment ] [ Designated as safety issue: No ]
  • Time to 2 g/dL increase in hemoglobin during the comparative treatment period [ Time Frame: during the comparative treatment period ] [ Designated as safety issue: No ]
  • Change in FACT-Fatigue scale score over time during the comparative treatment period [ Time Frame: during the comparative treatment period ] [ Designated as safety issue: No ]
  • Overall incidence of adverse events, serious adverse events and related adverse events as measured throughout study [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Slope of change in hemoglobin after the first month of treatment [ Time Frame: baseline to first month of treatment ] [ Designated as safety issue: No ]
  • Red blood cell usage during the treatment period and other changes in hemoglobin during the comparative treatment period [ Time Frame: during the comparative treatment period ] [ Designated as safety issue: No ]
  • Changes in hemoglobin during the maintenance period [ Time Frame: during the maintenance period ] [ Designated as safety issue: No ]

Enrollment: 718
Study Start Date: February 2003
Study Completion Date: April 2004
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00111137

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00111137     History of Changes
Other Study ID Numbers: 20020139
Study First Received: May 17, 2005
Last Updated: February 20, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
darbepoetin alfa
anemia
Amgen
Chemotherapy

Additional relevant MeSH terms:
Neoplasms
Darbepoetin alfa
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014