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Darbepoetin Alfa Compared With Epoetin Alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00070382
  Purpose

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.


Condition Intervention Phase
Cancer-Related Problem/Condition
Leukemia
Lymphoma
Lymphoproliferative Disorder
Multiple Myeloma and Plasma Cell Neoplasm
Precancerous/Nonmalignant Condition
Unspecified Adult Solid Tumor, Protocol Specific
Drug: darbepoetin alfa
Drug: epoetin alfa
Phase III

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Anemia Cancer Fungal Infections Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma
Drug Information available for: Epoetin alfa Erythropoietin Darbepoetin alfa
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Open Label, Active Control
Official Title: 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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 2003
Detailed Description:

OBJECTIVES:

Primary

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

Secondary

  • Compare the safety of these drugs in these patients.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of a non-myeloid malignancy

    • The following diagnoses are excluded:

      • Acute myeloid leukemia
      • Chronic myeloid leukemia
      • Acute lymphoblastic leukemia
      • Hairy cell leukemia
      • Burkitt's lymphoma
      • Lymphoblastic lymphoma
  • Currently receiving or planning to receive at least 8 weeks of cyclic cytotoxic chemotherapy
  • Hemoglobin no greater than 11.0 g/dL
  • No other primary hematologic disorder that would cause anemia (e.g., sickle cell anemia)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics

Hepatic

  • Bilirubin less than 2 times upper limit of normal (ULN)

Renal

  • Creatinine less than 2 times ULN

Cardiovascular

  • No angina
  • No congestive heart failure
  • No New York Heart Association class III or IV heart disease
  • No hypertension
  • No cardiac arrhythmia
  • No other unstable or uncontrolled disease or condition that would affect cardiac function

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No known seizure disorder
  • No known sensitivity to study agents
  • No clinically significant inflammatory disease (e.g., rheumatoid arthritis or Crohn's disease)
  • No confirmed neutralizing antibodies to epoetin alfa
  • No other disorder that would preclude study compliance or giving informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 30 days since prior darbepoetin alfa or epoetin alfa
  • No other concurrent epoetin alfas

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • More than 30 days since prior participation in investigational device or drug trials
  • No prior randomization to this study
  • No other concurrent investigational agents or procedures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00070382

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: John A. Glaspy, MD, MPH Jonsson Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: CDR0000333213, UCLA-0306021, AMGEN-20030125
Study First Received: October 3, 2003
Last Updated: November 16, 2008
ClinicalTrials.gov Identifier: NCT00070382  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
anemia
unspecified adult solid tumor, protocol specific
Waldenstrom macroglobulinemia
monoclonal gammopathy of undetermined significance
extramedullary plasmacytoma
isolated plasmacytoma of bone
refractory multiple myeloma
primary systemic amyloidosis
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
post-transplant lymphoproliferative disorder
angioimmunoblastic T-cell lymphoma
anaplastic large cell lymphoma
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent adult T-cell leukemia/lymphoma
stage I adult T-cell leukemia/lymphoma
stage II adult T-cell leukemia/lymphoma
stage III adult T-cell leukemia/lymphoma
stage IV adult T-cell leukemia/lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
recurrent mycosis fungoides/Sezary syndrome
stage I mycosis fungoides/Sezary syndrome
stage II mycosis fungoides/Sezary syndrome
stage III mycosis fungoides/Sezary syndrome
stage IV mycosis fungoides/Sezary syndrome
recurrent adult Hodgkin lymphoma

Study placed in the following topic categories:
Epoetin Alfa
Sezary syndrome
Hodgkin lymphoma, adult
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Lymphoma, large-cell, immunoblastic
Mycoses
Leukemia, Prolymphocytic
Hemorrhagic Disorders
Multiple myeloma
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large-Cell, Anaplastic
Hodgkin Disease
Chronic lymphocytic leukemia
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Hematologic Diseases
Blood Coagulation Disorders
Leukemia, B-cell, chronic
Darbepoetin alfa
Multiple Myeloma
Waldenstrom Macroglobulinemia
Plasmacytoma
Leukemia, T-Cell
Anaplastic large cell lymphoma
Lymphoma, Non-Hodgkin
Monoclonal gammopathy of undetermined significance
Lymphoma, T-Cell, Cutaneous
Leukemia, Lymphoid
Hodgkin's disease

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Hematinics
Therapeutic Uses
Hematologic Agents
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009