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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00070382
First received: October 3, 2003
Last updated: August 2, 2012
Last verified: August 2012

October 3, 2003
August 2, 2012
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 ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00070382 on ClinicalTrials.gov 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.

OBJECTIVES:

Primary

  • 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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
Not Provided
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00070382
CDR0000333213, P30CA016042, UCLA-0306021, AMGEN-20030125
Yes
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