Treatment for Patients With Non-Myeloid Malignancies Receiving Chemotherapy

February 20, 2008 updated by: Amgen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

718

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to hematopoietic response during the comparative treatment period
Time Frame: during the comparative treatment period
during the comparative treatment period

Secondary Outcome Measures

Outcome 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)
Time Frame: during the study
during the study
Incidence, if any, of neutralizing antibody formation to study drug
Time Frame: throughout study
throughout study
Difference between the average hemoglobin after the first month of treatment compared to the baseline hemoglobin
Time Frame: baseline to first month of treatment
baseline to first month of treatment
Time to 2 g/dL increase in hemoglobin during the comparative treatment period
Time Frame: during the comparative treatment period
during the comparative treatment period
Change in FACT-Fatigue scale score over time during the comparative treatment period
Time Frame: during the comparative treatment period
during the comparative treatment period
Overall incidence of adverse events, serious adverse events and related adverse events as measured throughout study
Time Frame: throughout study
throughout study
Slope of change in hemoglobin after the first month of treatment
Time Frame: baseline to first month of treatment
baseline to first month of treatment
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
during the comparative treatment period
Changes in hemoglobin during the maintenance period
Time Frame: during the maintenance period
during the maintenance period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

November 1, 2003

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

May 17, 2005

First Submitted That Met QC Criteria

May 17, 2005

First Posted (Estimate)

May 18, 2005

Study Record Updates

Last Update Posted (Estimate)

February 28, 2008

Last Update Submitted That Met QC Criteria

February 20, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20020139

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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