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
  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
Anemia
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ]

Enrollment: 14
Study Start Date: August 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Darbepoetin alfa
darbepoetin alfa administered once every two weeks at a dose of 200 ug over a 16 week treatment period.
Drug: darbepoetin alfa
darbepoetin alfa administered at a dose of 200ug once every 2 weeks over a 16-week treatment period
Active Comparator: Epoetin alfa
epoetin alfa administered at 40,000 unites, once per week 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

Detailed Description:

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:
Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00070382     History of Changes
Other Study ID Numbers: CDR0000333213, P30CA016042, UCLA-0306021, AMGEN-20030125
Study First Received: October 3, 2003
Last Updated: August 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Jonsson Comprehensive Cancer Center:
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

Additional relevant MeSH terms:
Anemia
Neoplasms
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Precancerous Conditions
Lymphoma, Large-Cell, Immunoblastic
Hematologic Diseases
Neoplasms by Histologic Type
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hemorrhagic Disorders
Darbepoetin alfa
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014