Clinical trial NCT00989092: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Anemia
Anemia of Cancer
Cancer
Carcinoma
Neoplasms
Non-Myeloid Malignancies
Keywords: anemia of cancer
darbepoetin alfa
Aranesp
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2009-10-02
Enrollment: 287
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).


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

Primary outcomes:
measure: Number of Participants Hospitalized During the Test Period
timeFrame: Weeks 1- 12
measure: Days of Hospitalization During the Test Period
timeFrame: Weeks 1-12
measure: Number of Hospitalizations During the Test Period
timeFrame: Weeks 1-12
Secondary outcomes:
measure: Total Hospital Costs During the Test Period
timeFrame: Weeks 1-12
measure: Change in Functional Assessment of Cancer Therapy (FACT)-Fatigue Score at Week 13
timeFrame: Baseline (Week 1) and Week 13
measure: Hemoglobin Response During the Test Period
timeFrame: Weeks 1-12
measure: Hematopoietic Response During the Test Period
timeFrame: Weeks 1-12
measure: Change From Baseline in Hemoglobin Level
timeFrame: Baseline (Week 1) and Week 13
measure: Number of Participants With Red Blood Cell (RBC) Transfusions During the Test Period
timeFrame: Weeks 1-12
measure: Number of Units of Red Blood Cells Transfused During the Test Period
timeFrame: Weeks 1-12
measure: Number of Days of Red Blood Cell Transfusions During the Test Period
timeFrame: Weeks 1-12
measure: Number of Participants With Red Blood Cell (RBC) Transfusions During Weeks 5-12
timeFrame: Weeks 5-12
measure: Number of Units of Red Blood Cells Transfused During Weeks 5-12
timeFrame: Weeks 5-12
measure: Number of Days of Red Blood Cell Transfusions During Weeks 5-12
timeFrame: Weeks 5-12
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
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.