Darbepoetin Alfa and Anemia of Cancer

This study has been terminated.
(slow enrollment and change in product development strategy)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00989092
First received: October 1, 2009
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

This phase 2, multicenter, randomized, open-label, comparative study was designed to determine the effect of darbepoetin alfa on hospital days, economic outcomes, and health related quality of life (HRQOL) in anemic patients with nonmyeloid malignancies who were not receiving chemotherapy. Participants were randomly assigned in a 4:1 allocation ratio to receive either 21 weeks of darbepoetin alfa treatment (treatment group) or 12 weeks of observation followed by up to 9 weeks of darbepoetin alfa treatment (observation group).


Condition Intervention Phase
Anemia
Anemia of Cancer
Cancer
Carcinoma
Neoplasms
Non-Myeloid Malignancies
Biological: darbepoetin alfa
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized, Open-label, Comparative Study to Estimate the Effect of Darbepoetin Alfa on Hospital Days, Economic Outcomes, and Health-related Quality of Life in Subjects With Nonmyeloid Malignancies and Anemia of Cancer

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Number of Participants Hospitalized During the Test Period [ Time Frame: Weeks 1- 12 ] [ Designated as safety issue: No ]
    Number of participants hospitalized during Weeks 1-12 as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire.

  • Days of Hospitalization During the Test Period [ Time Frame: Weeks 1-12 ] [ Designated as safety issue: No ]
    Number of days hospitalized during Weeks 1-12 as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire; participants who were not hospitalized had a value of 0 days.

  • Number of Hospitalizations During the Test Period [ Time Frame: Weeks 1-12 ] [ Designated as safety issue: No ]
    Number of times participants were hospitalized as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire during Weeks 1-12


Secondary Outcome Measures:
  • Total Hospital Costs During the Test Period [ Time Frame: Weeks 1-12 ] [ Designated as safety issue: No ]
    The hospital bill database was used to determine the mean total hospital cost per participant during the test period. Participants who were not hospitalized had a cost of $0 imputed.

  • Change in Functional Assessment of Cancer Therapy (FACT)-Fatigue Score at Week 13 [ Time Frame: Baseline (Week 1) and Week 13 ] [ Designated as safety issue: No ]
    The FACT-Fatigue scale comprises 13 questions evaluating the impact of anemia on cancer patients with various tumor types receiving chemotherapy. Fatigue scores range from 0 to 52, with a higher score indicating less fatigue.

  • Hemoglobin Response During the Test Period [ Time Frame: Weeks 1-12 ] [ Designated as safety issue: No ]
    The number of participants achieving a hemoglobin response, defined as an increase in hemoglobin from baseline of ≥ 2.0 g/dL in the absence of red blood cell (RBC) transfusions during the preceding 28 days.

  • Hematopoietic Response During the Test Period [ Time Frame: Weeks 1-12 ] [ Designated as safety issue: No ]
    The number of participants achieving a hematopoietic response, defined as an increase in hemoglobin from baseline of ≥ 2.0 g/dL or a concentration ≥ 12.0 g/dL both in the absence of red blood cell (RBC) transfusions during the preceding 28 days.

  • Change From Baseline in Hemoglobin Level [ Time Frame: Baseline (Week 1) and Week 13 ] [ Designated as safety issue: No ]
    The difference between hemoglobin concentrations after 12 weeks of treatment and the Baseline hemoglobin concentration value (Study Day 1 sample prior to first dose of darbepoetin alfa).

  • Number of Participants With Red Blood Cell (RBC) Transfusions During the Test Period [ Time Frame: Weeks 1-12 ] [ Designated as safety issue: No ]
    Number of participants with at least one RBC transfusion during Weeks 1 to 12.

  • Number of Units of Red Blood Cells Transfused During the Test Period [ Time Frame: Weeks 1-12 ] [ Designated as safety issue: No ]
    The average number of standard units of red blood cells transfused during Weeks 1 to 12.

  • Number of Days of Red Blood Cell Transfusions During the Test Period [ Time Frame: Weeks 1-12 ] [ Designated as safety issue: No ]
    The number of days when at least one red blood cell transfusion was administered during Weeks 1 to 12.

  • Number of Participants With Red Blood Cell (RBC) Transfusions During Weeks 5-12 [ Time Frame: Weeks 5-12 ] [ Designated as safety issue: No ]
    The number of participants with at least one RBC transfusion during weeks 5 to 12.

  • Number of Units of Red Blood Cells Transfused During Weeks 5-12 [ Time Frame: Weeks 5-12 ] [ Designated as safety issue: No ]
    The number of standard units of RBCs transfused during Weeks 5 to 12.

  • Number of Days of Red Blood Cell Transfusions During Weeks 5-12 [ Time Frame: Weeks 5-12 ] [ Designated as safety issue: No ]
    The number of days when at least one RBC transfusion was administered during Weeks 5 to 12.


Enrollment: 287
Study Start Date: May 2002
Study Completion Date: June 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Observational Group
Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered to the observation group during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participants hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
Biological: darbepoetin alfa
Administered subcutaneously.
Other Name: Aranesp®
Active Comparator: 21 week treatment group
Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at week 7 (to 5.0 μg/kg once every 2 weeks) or at week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at week 7.
Biological: darbepoetin alfa
Administered subcutaneously.
Other Name: Aranesp®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • nonmyeloid malignancies (including lymphocytic leukemias)
  • anemia (hemoglobin concentration less than or equal to 11.0 g/dL) due to cancer and/or previous chemotherapy or radiotherapy
  • Eastern Cooperative Oncology Group performance status of 0 to 2
  • adequate liver and renal functions
  • 18 years or older

Exclusion Criteria:

  • history of recombinant human erythropoietin therapy, cytotoxic chemotherapy, or more than 30 Gy radiotherapy to the whole pelvis within 4 weeks before screening
  • acute myelogenous leukemia, chronic myelogenous leukemia, or myelodysplastic syndrome
  • known hematologic disorders that could cause anemia
  • inflammatory or cardiac disorders
  • previous positive antibody response to any erythropoietic agent
  • history of pure red cell aplasia
  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: NCT00989092

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

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00989092     History of Changes
Other Study ID Numbers: 20000219
Study First Received: October 1, 2009
Results First Received: September 3, 2010
Last Updated: December 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
anemia of cancer
darbepoetin alfa
Aranesp

Additional relevant MeSH terms:
Anemia
Neoplasms
Hematologic Diseases
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014