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OpenTrials
Completed

NCT Number: NCT00111137

Treatment for Patients With Non-Myeloid Malignancies Receiving Chemotherapy

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.

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Key information

Conditions

Cancer Anemia Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Non-Myeloid Malignancies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rHuEPO

Drug

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

darbepoetin alfa

Drug

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

Primary outcomes

  1. Time to hematopoietic response during the comparative treatment period

    Time frame: during the comparative treatment period

Secondary outcomes

  1. 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

  2. Incidence, if any, of neutralizing antibody formation to study drug

    Time frame: throughout study

  3. Difference between the average hemoglobin after the first month of treatment compared to the baseline hemoglobin

    Time frame: baseline to first month of treatment

  4. Time to 2 g/dL increase in hemoglobin during the comparative treatment period

    Time frame: during the comparative treatment period

  5. Change in FACT-Fatigue scale score over time during the comparative treatment period

    Time frame: during the comparative treatment period

  6. Overall incidence of adverse events, serious adverse events and related adverse events as measured throughout study

    Time frame: throughout study

  7. Slope of change in hemoglobin after the first month of treatment

    Time frame: baseline to first month of treatment

  8. 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

  9. Changes in hemoglobin during the maintenance period

    Time frame: during the maintenance period

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2003
Study completion
2004
First posted
May 18, 2005
Registry last updated
Feb 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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