Darbepoetin Alfa and Anemia of Cancer

Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00989092
• Other study ID #: 20000219
• Status: Terminated
• Phase: Phase 2
• First received: October 1, 2009
• Last updated: December 11, 2013
• Start date: May 2002
• Est. completion date: June 2004

Study information

• Verified date: December 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 287
• Est. completion date: June 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anemia
• Anemia of Cancer
• Cancer
• Carcinoma
• Neoplasms
• Non-Myeloid Malignancies

Intervention

Biological:
• darbepoetin alfa
Administered subcutaneously.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   AmgenTrials clinical trials website