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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014