Back to resultsDarbepoetin Alfa and Anemia of Cancer
Primary Purpose
Anemia, Anemia of Cancer, Cancer
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
darbepoetin alfa
Sponsored by
About this trial
This is an interventional supportive care trial for Anemia focused on measuring anemia of cancer, darbepoetin alfa, Aranesp
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Observational Group
21 week treatment group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of Participants Hospitalized During the Test Period
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
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
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
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
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
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
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
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
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
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
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
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
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
The number of days when at least one RBC transfusion was administered during Weeks 5 to 12.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00989092
Brief Title
Darbepoetin Alfa and Anemia of Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Terminated
Why Stopped
slow enrollment and change in product development strategy
Study Start Date
May 2002 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
June 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Anemia of Cancer, Cancer, Carcinoma, Neoplasms, Non-Myeloid Malignancies
Keywords
anemia of cancer, darbepoetin alfa, Aranesp
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
287 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Observational Group
Arm Type
Other
Arm Description
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.
Arm Title
21 week treatment group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
darbepoetin alfa
Other Intervention Name(s)
Aranesp®
Intervention Description
Administered subcutaneously.
Primary Outcome Measure Information:
Title
Number of Participants Hospitalized During the Test Period
Description
Number of participants hospitalized during Weeks 1-12 as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire.
Time Frame
Weeks 1- 12
Title
Days of Hospitalization During the Test Period
Description
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.
Time Frame
Weeks 1-12
Title
Number of Hospitalizations During the Test Period
Description
Number of times participants were hospitalized as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire during Weeks 1-12
Time Frame
Weeks 1-12
Secondary Outcome Measure Information:
Title
Total Hospital Costs During the Test Period
Description
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.
Time Frame
Weeks 1-12
Title
Change in Functional Assessment of Cancer Therapy (FACT)-Fatigue Score at Week 13
Description
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.
Time Frame
Baseline (Week 1) and Week 13
Title
Hemoglobin Response During the Test Period
Description
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.
Time Frame
Weeks 1-12
Title
Hematopoietic Response During the Test Period
Description
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.
Time Frame
Weeks 1-12
Title
Change From Baseline in Hemoglobin Level
Description
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).
Time Frame
Baseline (Week 1) and Week 13
Title
Number of Participants With Red Blood Cell (RBC) Transfusions During the Test Period
Description
Number of participants with at least one RBC transfusion during Weeks 1 to 12.
Time Frame
Weeks 1-12
Title
Number of Units of Red Blood Cells Transfused During the Test Period
Description
The average number of standard units of red blood cells transfused during Weeks 1 to 12.
Time Frame
Weeks 1-12
Title
Number of Days of Red Blood Cell Transfusions During the Test Period
Description
The number of days when at least one red blood cell transfusion was administered during Weeks 1 to 12.
Time Frame
Weeks 1-12
Title
Number of Participants With Red Blood Cell (RBC) Transfusions During Weeks 5-12
Description
The number of participants with at least one RBC transfusion during weeks 5 to 12.
Time Frame
Weeks 5-12
Title
Number of Units of Red Blood Cells Transfused During Weeks 5-12
Description
The number of standard units of RBCs transfused during Weeks 5 to 12.
Time Frame
Weeks 5-12
Title
Number of Days of Red Blood Cell Transfusions During Weeks 5-12
Description
The number of days when at least one RBC transfusion was administered during Weeks 5 to 12.
Time Frame
Weeks 5-12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
17602062
Citation
Charu V, Belani CP, Gill AN, Bhatt M, Tomita D, Rossi G, Ben-Jacob A. Efficacy and safety of every-2-week darbepoetin alfa in patients with anemia of cancer: a controlled, randomized, open-label phase II trial. Oncologist. 2007 Jun;12(6):727-37. doi: 10.1634/theoncologist.12-6-727.
Results Reference
result
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Darbepoetin Alfa and Anemia of Cancer
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