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Epoetin Alfa in Treating Patients With Anemia Who Are Undergoing Chemotherapy for Cancer

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ClinicalTrials.gov Identifier: NCT00255749
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : October 4, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Brief Summary:

RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat anemia caused by cancer and chemotherapy.

PURPOSE: This randomized phase II trial is studying how well epoetin alfa works in treating patients with anemia who are undergoing chemotherapy for cancer.

Condition or disease Intervention/treatment Phase
Anemia Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Precancerous Condition Unspecified Adult Solid Tumor, Protocol Specific Biological: epoetin alfa Phase 2

Detailed Description:



  • Determine the efficacy, in terms of maintenance of target hemoglobin and hematocrit levels, of interval dosing with epoetin alfa in patients with anemia undergoing chemotherapy for nonmyeloid cancer.
  • Determine the safety of this drug in these patients.


  • Determine the quality of life of patients treated with this drug.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I (early intervention): Patients receive epoetin alfa subcutaneously on day 1. Treatment repeats every 21 days for up to 5 courses.
  • Arm II (standard intervention): Patients receive epoetin alfa as in arm I once their hemoglobin level is ≤ 10.5 g/dL.

Quality of life is assessed prior to start of study treatment, at week 7 during study treatment, and after completion of study treatment.

After completion of study treatment, patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Assessment of Early and Standard Intervention With Procrit® (Epoetin Alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients With Cancer Receiving Chemotherapy
Study Start Date : August 2005
Primary Completion Date : April 2007

Arm Intervention/treatment
Experimental: early intervention epoietin alfa
Patients receive epoetin alfa subcutaneously on day 1. Treatment repeats every 21 days for up to 5 courses.
Biological: epoetin alfa
standard intervention epoietin alfa
Patients receive epoetin alfa as in arm I once their hemoglobin level is ≤ 10.5 g/dL.
Biological: epoetin alfa

Primary Outcome Measures :
  1. Efficacy [ Time Frame: 7 weeks ]
  2. Safety [ Time Frame: 7 weeks ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 7 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed nonmyeloid cancer

    • No history of myelodysplasia
  • Baseline hemoglobin 11-12 g/dL
  • No anemia due to factors other than cancer or chemotherapy (e.g., iron, cyanocobalamin [vitamin B_12], or folate deficiencies, hemolysis, or gastrointestinal bleeding)
  • Receiving chemotherapy that meets the following criteria:

    • Administered weekly OR every 3 weeks
    • Must begin chemotherapy on or before the first day of study treatment
  • No known, untreated CNS metastases


Performance status

  • ECOG 0-2

Life expectancy

  • At least 6 months


  • See Disease Characteristics
  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3 (transfusion independent)
  • Iron transferrin saturation > 20%
  • No history of chronic hypercoagulable disorders (e.g., activated protein C resistance, anti-cardiolipin disorder, protein C deficiency, or protein S deficiency)


  • Bilirubin < 2.0 mg/dL
  • SGPT ≤ 3 times upper limit of normal


  • Creatinine ≤ 1.5 mg/dL
  • No significant, uncontrolled genitourinary disease or dysfunction


  • No uncontrolled cardiac arrhythmia in the past 6 months
  • No uncontrolled hypertension
  • No deep vein thrombosis, ischemic stroke, or other arterial or venous thrombotic events

    • Superficial thromboses allowed
  • No other significant, uncontrolled cardiovascular disease or dysfunction


  • No significant, uncontrolled pulmonary disease or dysfunction
  • No pulmonary emboli


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No infection requiring hospitalization or antibiotics in the past 14 days
  • No known hypersensitivity to mammalian cell-derived products or to human albumin
  • No new onset (in the past 3 months) poorly controlled seizures
  • No other active malignancy except basal cell carcinoma or carcinoma in situ
  • Not an employee of the investigator or study center or family members of the employee or the investigator
  • No significant, uncontrolled neurological, endocrine, or gastrointestinal disease or dysfunction


Biologic therapy

  • See Chemotherapy
  • More than 3 months since prior erythropoietic agent (e.g., epoetin alfa, darbepoetin alfa, or gene-activated erythropoietin)
  • More than 4 weeks since prior packed red blood cell transfusion
  • No concurrent stem cell harvest of bone marrow
  • No concurrent interleukin-11
  • No other concurrent erythropoietic agent


  • See Disease Characteristics
  • No concurrent high-dose chemotherapy with stem cell transplantation


  • No concurrent nonpalliative radiotherapy


  • More than 2 weeks since prior major surgery


  • At least 1 month since prior investigational agents or devices
  • No concurrent high-dose IV iron supplementation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00255749

United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: John A. Glaspy, MD, MPH Jonsson Comprehensive Cancer Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00255749     History of Changes
Other Study ID Numbers: CDR0000449950
First Posted: November 21, 2005    Key Record Dates
Last Update Posted: October 4, 2012
Last Verified: October 2012

Keywords provided by Jonsson Comprehensive Cancer Center:
adult acute lymphoblastic leukemia in remission
progressive hairy cell leukemia, initial treatment
stage 0 chronic lymphocytic leukemia
extramedullary plasmacytoma
isolated plasmacytoma of bone
refractory multiple myeloma
monoclonal gammopathy of undetermined significance
primary systemic amyloidosis
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
AIDS-related peripheral/systemic lymphoma
AIDS-related primary CNS lymphoma
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult Hodgkin lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult T-cell leukemia/lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoproliferative Disorders
Precancerous Conditions
Neoplasms by Histologic Type
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Epoetin Alfa