Darbepoetin Alfa and Anemia of Cancer

Study Overview
=================
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).

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

Conditions
-----------------
Anemia, Anemia of Cancer, Cancer, Carcinoma, Neoplasms, Non-Myeloid Malignancies

Intervention / Treatment
-----------------
* Biological: darbepoetin alfa


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Observational Group<br>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<br>* Administered subcutaneously.<br>* Other names: Aranesp®;|
| Active Comparator: 21 week treatment group<br>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<br>* Administered subcutaneously.<br>* Other names: Aranesp®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Weeks 1- 12 | 
| 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. | Weeks 1-12 | 
| 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 | Weeks 1-12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Weeks 1-12 | 
| 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. | Baseline (Week 1) and Week 13 | 
| 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. | Weeks 1-12 | 
| 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. | Weeks 1-12 | 
| 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). | Baseline (Week 1) and Week 13 | 
| 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. | Weeks 1-12 | 
| 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. | Weeks 1-12 | 
| 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. | Weeks 1-12 | 
| 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. | Weeks 5-12 | 
| 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. | Weeks 5-12 | 
| 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. | Weeks 5-12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anemia of cancer, darbepoetin alfa, Aranesp