Darbepoetin Alfa and Anemia of Cancer

NCT00989092 | Terminated Phase 2 Results

• 1 other identifier: 20000219
• Study Type: interventional
• Target: 287
• Locations: 0 countries
• Sites: N/A

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).

Conditions

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

Keywords

anemia of cancer; darbepoetin alfa; Aranesp

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• Total Hospital Costs During the Test Period

  Weeks 1-12

• Change in Functional Assessment of Cancer Therapy (FACT)-Fatigue Score at Week 13

  Baseline (Week 1) and Week 13

• Hemoglobin Response During the Test Period

  Weeks 1-12

• Hematopoietic Response During the Test Period

  Weeks 1-12

• Change From Baseline in Hemoglobin Level

  Baseline (Week 1) and Week 13

Study Arms (2)

Observational Group

OTHER

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

21 week treatment group

ACTIVE COMPARATOR

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

Interventions

darbepoetin alfa BIOLOGICAL

Administered subcutaneously.

Also known as: Aranesp®

21 week treatment group; Observational Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Related 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. doi: 10.1634/theoncologist.12-6-727.

  PMID: 17602062 RESULT

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Anemia; Neoplasms; Carcinoma

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2009
• First Posted: October 2, 2009
• Study Start: May 1, 2002
• Primary Completion: January 1, 2004
• Study Completion: June 1, 2004
• Last Updated: January 29, 2014
• Results First Posted: January 29, 2014

Record last verified: 2013-12