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Darbepoetin Alfa and Anemia of Cancer

11 december 2013 bijgewerkt door: Amgen

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

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).

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

287

Fase

  • Fase 2

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: 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.
Biologisch: darbepoetin alfa
Administered subcutaneously.
Andere namen:
  • Aranesp®
Actieve vergelijker: 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.
Biologisch: darbepoetin alfa
Administered subcutaneously.
Andere namen:
  • Aranesp®

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants Hospitalized During the Test Period
Tijdsspanne: Weeks 1- 12
Number of participants hospitalized during Weeks 1-12 as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire.
Weeks 1- 12
Days of Hospitalization During the Test Period
Tijdsspanne: Weeks 1-12
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.
Weeks 1-12
Number of Hospitalizations During the Test Period
Tijdsspanne: Weeks 1-12
Number of times participants were hospitalized as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire during Weeks 1-12
Weeks 1-12

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Total Hospital Costs During the Test Period
Tijdsspanne: Weeks 1-12
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.
Weeks 1-12
Change in Functional Assessment of Cancer Therapy (FACT)-Fatigue Score at Week 13
Tijdsspanne: Baseline (Week 1) and Week 13
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.
Baseline (Week 1) and Week 13
Hemoglobin Response During the Test Period
Tijdsspanne: Weeks 1-12
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.
Weeks 1-12
Hematopoietic Response During the Test Period
Tijdsspanne: Weeks 1-12
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.
Weeks 1-12
Change From Baseline in Hemoglobin Level
Tijdsspanne: Baseline (Week 1) and Week 13
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).
Baseline (Week 1) and Week 13
Number of Participants With Red Blood Cell (RBC) Transfusions During the Test Period
Tijdsspanne: Weeks 1-12
Number of participants with at least one RBC transfusion during Weeks 1 to 12.
Weeks 1-12
Number of Units of Red Blood Cells Transfused During the Test Period
Tijdsspanne: Weeks 1-12
The average number of standard units of red blood cells transfused during Weeks 1 to 12.
Weeks 1-12
Number of Days of Red Blood Cell Transfusions During the Test Period
Tijdsspanne: Weeks 1-12
The number of days when at least one red blood cell transfusion was administered during Weeks 1 to 12.
Weeks 1-12
Number of Participants With Red Blood Cell (RBC) Transfusions During Weeks 5-12
Tijdsspanne: Weeks 5-12
The number of participants with at least one RBC transfusion during weeks 5 to 12.
Weeks 5-12
Number of Units of Red Blood Cells Transfused During Weeks 5-12
Tijdsspanne: Weeks 5-12
The number of standard units of RBCs transfused during Weeks 5 to 12.
Weeks 5-12
Number of Days of Red Blood Cell Transfusions During Weeks 5-12
Tijdsspanne: Weeks 5-12
The number of days when at least one RBC transfusion was administered during Weeks 5 to 12.
Weeks 5-12

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Amgen

Publicaties en nuttige links

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Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 mei 2002

Primaire voltooiing (Werkelijk)

1 januari 2004

Studie voltooiing (Werkelijk)

1 juni 2004

Studieregistratiedata

Eerst ingediend

1 oktober 2009

Eerst ingediend dat voldeed aan de QC-criteria

1 oktober 2009

Eerst geplaatst (Schatting)

2 oktober 2009

Updates van studierecords

Laatste update geplaatst (Schatting)

29 januari 2014

Laatste update ingediend die voldeed aan QC-criteria

11 december 2013

Laatst geverifieerd

1 december 2013

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 20000219

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