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Epoetin Alfa in Treating Anemia in Patients Who Are Receiving Chemotherapy

This study has been completed.

Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003600
  Purpose

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

PURPOSE: Randomized double blinded phase III trial to compare the effectiveness of epoetin alfa with a placebo in treating anemia in cancer patients who are receiving chemotherapy.


Condition Intervention Phase
Anemia
Breast Cancer
Chronic Myeloproliferative Disorders
Drug/Agent Toxicity by Tissue/Organ
Leukemia
Lung Cancer
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Precancerous/Nonmalignant Condition
Quality of Life
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: epoetin alfa
Procedure: quality-of-life assessment
Phase III

Genetics Home Reference related topics:   aceruloplasminemia    breast cancer    hemophilia   

MedlinePlus related topics:   Anemia    Breast Cancer    Cancer    Fungal Infections    Hodgkin's Disease    Intestinal Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Lung Cancer    Lymphoma    Multiple Myeloma   

ChemIDplus related topics:   Epoetin alfa    Erythropoietin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Randomized, Double-Blind, Active Control
Official Title:   A Phase III Randomized Double-Blind Study of Erythropoietin Versus Placebo in Anemic Patients With Cancer Undergoing Chemotherapy

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

Study Start Date:   December 1998

Detailed Description:

OBJECTIVES: I. Determine whether epoetin alfa treatment improves the quality of life in anemic patients who are undergoing chemotherapy for advanced malignancy. II. Determine whether epoetin alfa increases hemoglobin levels and decreases transfusion requirements in these patients. III. Validate or refute the use of an algorithm using pre- and posttreatment epoetin alfa, ferritin, and hemoglobin levels to predict 16 weeks response or no response to therapeutic doses of epoetin alfa as set forth by these patients. IV. Explore whether anemic patients receiving platinum-containing chemotherapy regimens experience less nephrotoxicity if they receive concurrent epoetin alfa compared to those who receive placebo.

OUTLINE: This is a randomized, double blind study. Patients are stratified by primary malignant disease (lung vs breast vs other), life expectancy (4-6 months vs greater than 6 months), planned concurrent radiotherapy (yes vs no), and degree of anemia (mild or at least 9 g/dL vs severe or less than 9 g/dL). Patients receiving chemotherapy are randomized to receive epoetin alfa subcutaneously once a week for a maximum of 16 weeks (arm I) or placebo subcutaneously once a week for a maximum of 16 weeks (arm II). Quality of life is assessed at randomization and monthly throughout study. Patients are followed every 6 months for 1 year.

PROJECTED ACCRUAL: There will be 300 patients (150 patients per arm) accrued into this study over 11 months.

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

Criteria

DISEASE CHARACTERISTICS: Anemic: Hemoglobin in males less than 11.5 g/dL; hemoglobin in females less than 10.0 g/dL No anemia secondary to B12, folic acid, or iron deficiency No anemia secondary to gastrointestinal bleed or hemolysis No anemia secondary to a primary or chemotherapy-induced myelodysplastic syndrome No anemia secondary to acute lymphocytic leukemia Histologically confirmed advanced malignancy Lung Breast Other Currently receiving myelosuppressive, cytotoxic chemotherapy for advanced cancer No patients receiving adjuvant therapy for cancer that has been surgically removed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 4 months Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified Cardiovascular: No uncontrolled hypertension (systolic at least 180, diastolic at least 100) Other: Normal or elevated ferritin No known hypersensitivity to epoetin alfa Must be able to reliably take oral medication Must be alert and mentally competent Not pregnant or nursing

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 year since prior epoetin alfa At least 2 weeks since prior red blood cell transfusions No concurrent peripheral blood stem cell or bone marrow transplantation Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Concurrent radiotherapy allowed Surgery: See Disease Characteristics

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003600

Locations
United States, Arizona
CCOP - Scottsdale Oncology Program    
      Scottsdale, Arizona, United States, 85259-5404
United States, District of Columbia
Howard University Cancer Center    
      Washington, District of Columbia, United States, 20060
United States, Illinois
CCOP - Carle Cancer Center    
      Urbana, Illinois, United States, 61801
CCOP - Illinois Oncology Research Association    
      Peoria, Illinois, United States, 61602
United States, Iowa
CCOP - Cedar Rapids Oncology Project    
      Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association    
      Des Moines, Iowa, United States, 50309-1016
Siouxland Hematology-Oncology    
      Sioux City, Iowa, United States, 51101-1733
United States, Kansas
CCOP - Wichita    
      Wichita, Kansas, United States, 67214-3882
United States, Louisiana
CCOP - Ochsner    
      New Orleans, Louisiana, United States, 70121
United States, Minnesota
CCOP - Duluth    
      Duluth, Minnesota, United States, 55805
CentraCare Clinic    
      Saint Cloud, Minnesota, United States, 56303
Mayo Clinic Cancer Center    
      Rochester, Minnesota, United States, 55905
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium    
      Omaha, Nebraska, United States, 68131
United States, North Dakota
Altru Health Systems    
      Grand Forks, North Dakota, United States, 58201
CCOP - Merit Care Hospital    
      Fargo, North Dakota, United States, 58122
Medcenter One Health System    
      Bismarck, North Dakota, United States, 58501
United States, Ohio
CCOP - Toledo Community Hospital Oncology Program    
      Toledo, Ohio, United States, 43623-3456
United States, Pennsylvania
CCOP - Geisinger Clinic and Medical Center    
      Danville, Pennsylvania, United States, 17822-2001
United States, South Dakota
CCOP - Sioux Community Cancer Consortium    
      Sioux Falls, South Dakota, United States, 57105-1080
Rapid City Regional Hospital    
      Rapid City, South Dakota, United States, 57709
Canada, Saskatchewan
Allan Blair Cancer Centre    
      Regina, Saskatchewan, Canada, S4T 7T1

Sponsors and Collaborators
North Central Cancer Treatment Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Thomas E. Witzig, MD     Mayo Clinic    
  More Information

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

Study ID Numbers:   CDR0000066673, NCCTG-979253, NCI-P98-0133
First Received:   November 1, 1999
Last Updated:   August 8, 2008
ClinicalTrials.gov Identifier:   NCT00003600
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III adult Hodgkin lymphoma  
stage IV adult Hodgkin lymphoma  
stage IV breast cancer  
stage IIIA breast cancer  
recurrent breast cancer  
monoclonal gammopathy of undetermined significance  
stage IIIB breast cancer  
recurrent non-small cell lung cancer  
recurrent adult Hodgkin lymphoma  
stage III cutaneous T-cell non-Hodgkin lymphoma  
stage IV cutaneous T-cell non-Hodgkin lymphoma  
recurrent cutaneous T-cell non-Hodgkin lymphoma  
isolated plasmacytoma of bone  
extramedullary plasmacytoma  
refractory plasma cell neoplasm  
Waldenstrom macroglobulinemia
stage III multiple myeloma
extensive stage small cell lung cancer
recurrent small cell lung cancer
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
recurrent adult acute myeloid leukemia
relapsing chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
small intestine lymphoma
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
unspecified adult solid tumor, protocol specific
chronic phase chronic myelogenous leukemia

Study placed in the following topic categories:
Epoetin Alfa
Thoracic Neoplasms
Blast Crisis
Sezary syndrome
Chronic myelogenous leukemia
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Lymphoma, large-cell, immunoblastic
Leukemia, Prolymphocytic
Hemorrhagic Disorders
Lung Neoplasms
Hemorrhagic thrombocythemia
Lymphoma, Large-Cell, Anaplastic
Neoplasm Metastasis
Thrombocythemia, Hemorrhagic
Essential thrombocytosis
Non-small cell lung cancer
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Blood Coagulation Disorders
Acute myelogenous leukemia
Breast Neoplasms
Leukemia, Myeloid
Waldenstrom Macroglobulinemia
Plasmacytoma
Leukemia, Myeloid, Accelerated Phase
Lung Diseases
B-cell lymphomas
Anaplastic large cell lymphoma
Lymphoma, Non-Hodgkin

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Blood Protein Disorders
Hematinics
Hematologic Agents
Ileal Diseases
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Jejunal Diseases
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 27, 2008




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