Darbepoetin Alfa Compared With Epoetin Alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00070382
Recruitment Status : Completed
First Posted : October 7, 2003
Last Update Posted : October 2, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

October 3, 2003
October 7, 2003
October 2, 2015
August 2003
November 2003   (Final data collection date for primary outcome measure)
Compare Efficacy of darbepoetin alfa with Epoetin Alfa as measured by the incidence of red blood cell transfusions. [ Time Frame: 12 weeks ]
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Complete list of historical versions of study NCT00070382 on Archive Site
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Darbepoetin Alfa Compared With Epoetin Alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer
A Randomized, Open-Label, Multicenter Study Of Darbepoetin Alfa Administered Once Every Two Weeks (Q2W) Compared With rHuEPO Administered Once Every Week (QW) For The Treatment Of Anemia In Subjects With Non-Myeloid Malignancies Receiving Multiple Chemotherapy

RATIONALE: Darbepoetin alfa and epoetin alfa may stimulate red blood cell production and treat anemia in patients who are receiving chemotherapy. It is not yet known whether darbepoetin alfa is more effective than epoetin alfa in treating patients with anemia.

PURPOSE: Randomized phase III trial to compare the effectiveness of darbepoetin alfa with that of epoetin alfa in treating anemia in patients who are receiving chemotherapy for cancer.



  • Compare the efficacy of darbepoetin alfa vs epoetin alfa for anemia in patients with non-myeloid malignancies receiving chemotherapy.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to screening hemoglobin concentration (less than 10.0 g/dL vs 10.0-11.0 g/dL) and type of concurrent chemotherapy (platinum-based vs non-platinum-based). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive darbepoetin alfa subcutaneously (SC) every other week for 12 weeks (i.e., on weeks 1, 3, 5, 7, 9, and 11).
  • Arm II: Patients receive epoetin alfa SC once weekly for 12 weeks. Patients are followed at 1 and 3 weeks .

PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study within 6 months.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Anemia
  • Leukemia
  • Lymphoma
  • Lymphoproliferative Disorder
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Precancerous/Nonmalignant Condition
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: darbepoetin alfa
    darbepoetin alfa administered at a dose of 200ug once every 2 weeks over a 16-week treatment period
  • Drug: epoetin alfa
    epoetin alfa administered at a dose of 40,000U once every week over a 16-week treatment period
  • Experimental: Darbepoetin alfa
    darbepoetin alfa administered once every two weeks at a dose of 200 ug over a 16 week treatment period.
    Intervention: Drug: darbepoetin alfa
  • Active Comparator: Epoetin alfa
    epoetin alfa administered at 40,000 unites, once per week over a 16-week treatment period.
    Intervention: Drug: epoetin alfa
20030125 Study Group Trial, Glaspy J, Vadhan-Raj S, Patel R, Bosserman L, Hu E, Lloyd RE, Boccia RV, Tomita D, Rossi G. Randomized comparison of every-2-week darbepoetin alfa and weekly epoetin alfa for the treatment of chemotherapy-induced anemia: the 20030125 Study Group Trial. J Clin Oncol. 2006 May 20;24(15):2290-7.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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November 2003   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of a non-myeloid malignancy
  • Currently receiving or planning to receive at least 8 weeks of cyclic cytotoxic chemotherapy
  • Hemoglobin no greater than 11.0 g/dL
  • 18 and over
  • ECOG 0-2
  • Bilirubin less than 2 times upper limit of normal (ULN)
  • Creatinine less than 2 times ULN
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • More than 30 days since prior darbepoetin alfa or epoetin alfa
  • More than 30 days since prior participation in investigational device or drug trials

Exclusion Criteria:

  • The following diagnoses are excluded:

    • Acute myeloid leukemia
    • Chronic myeloid leukemia
    • Acute lymphoblastic leukemia
    • Hairy cell leukemia
    • Burkitt's lymphoma
    • Lymphoblastic lymphoma
  • other primary hematologic disorder that would cause anemia (e.g., sickle cell anemia)
  • angina
  • congestive heart failure
  • New York Heart Association class III or IV heart disease
  • hypertension
  • cardiac arrhythmia
  • other unstable or uncontrolled disease or condition that would affect cardiac function
  • pregnant or nursing
  • known seizure disorder
  • known sensitivity to study agents
  • clinically significant inflammatory disease (e.g., rheumatoid arthritis or Crohn's disease)
  • confirmed neutralizing antibodies to epoetin alfa
  • other disorder that would preclude study compliance or giving informed consent
  • other concurrent epoetin alfas
  • prior randomization to this study
  • other concurrent investigational agents or procedures
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
P30CA016042 ( U.S. NIH Grant/Contract )
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Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: John A. Glaspy, MD, MPH Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP