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Epoetin Alfa in Treating Anemia in Patients With Solid Tumors

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00058331
  Purpose

RATIONALE: Epoetin alfa may stimulate red blood cell production and treat anemia in patients with solid tumors. It is not yet known whether epoetin alfa given once a week is more effective than epoetin alfa given once every 3 weeks in treating anemia.

PURPOSE: Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients who have solid tumors.


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: 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   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Randomized, Active Control
Official Title:   A Phase III, Randomized Study Of Two Different Dosing Schedules Of Erythropoetin In Anemic Patients With Cancer

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

Study Start Date:   June 2003

Detailed Description:

OBJECTIVES:

  • Compare the effects of 2 different schedules of epoetin alfa on decreasing transfusion requirements in anemic patients with nonmyeloid cancer.
  • Compare the effects of these regimens on increasing hemoglobin levels in these patients.
  • Compare the effects of these regimens on overall quality of life (QOL) and anemia-specific components of QOL in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to concurrent chemotherapy or radiotherapy (yes vs no), concurrent platinum-based (cisplatin or carboplatin) chemotherapy (yes vs no), degree of anemia (mild [hemoglobin at least 9.0 g/dL] vs severe [hemoglobin less than 9.0 g/dL]), age (60 and under vs over 60), and type of neoplasm (plasma cell disorder [including multiple myeloma] or lymphoproliferative disorder [including non-Hodgkin's lymphoma and chronic lymphocytic leukemia] vs all other neoplasms).

All patients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. Patients are then randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive EPO SC once weekly for 18 weeks.
  • Arm II: Patients receive EPO SC on day 1 of weeks 4, 7, 10, 13, 16, and 19. Quality of life is assessed at randomization at then monthly during study treatment.

Patients are followed every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 330 patients (165 per treatment arm) will be accrued for this study.

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

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of a nonmyeloid cancer (excluding nonmelanoma skin cancer)
  • Anemia secondary to cancer or cancer treatment*

    • Hemoglobin less than 12 g/dL (males)
    • Hemoglobin less than 11 g/dL (females) NOTE: *Active anticancer therapy is not required for study enrollment
  • Anemia must not be secondary to any of the following:

    • B_12, folic acid, or iron deficiency

      • Ferritin must be normal or elevated
    • Gastrointestinal bleeding or hemolysis
    • Primary or chemotherapy-induced myelodysplastic syndromes
  • No untreated CNS metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 6 months

Hematopoietic

  • See Disease Characteristics

Hepatic

  • Not specified

Renal

  • Not specified

Cardiovascular

  • No history of uncontrolled cardiac arrhythmias
  • No history of deep venous thrombosis within the past year (unless on anticoagulation)
  • No uncontrolled hypertension (systolic blood pressure at least 180 mm Hg and diastolic blood pressure at least 100 mm Hg) within the past year (unless on anticoagulation)

Pulmonary

  • No history of pulmonary embolism within the past year (unless on anticoagulation)

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • No known hypersensitivity to epoetin alfa, mammalian cell-derived products, or human albumin
  • No new onset of seizures within the past 3 months
  • No poorly controlled seizures
  • Able and willing to complete quality of life forms
  • Alert and mentally competent to give informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 6 months since prior epoetin alfa
  • More than 6 months since any prior investigational forms of epoetin alfa (e.g., gene-activated epoetin alfa or novel erythropoiesis-stimulating protein)
  • No concurrent peripheral blood stem cell transplantation
  • No concurrent bone marrow transplantation

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • More than 14 days since prior major surgery

Other

  • More than 2 weeks since prior red blood cell transfusions
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00058331

Locations
United States, Arizona
CCOP - Mayo Clinic Scottsdale Oncology Program    
      Scottsdale, Arizona, United States, 85259-5404
United States, Florida
Mayo Clinic    
      Jacksonville, Florida, United States, 32224
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 - 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, Michigan
CCOP - Michigan Cancer Research Consortium    
      Ann Arbor, Michigan, United States, 48106
United States, Minnesota
CCOP - Duluth    
      Duluth, Minnesota, United States, 55805
Mayo Clinic Cancer Center    
      Rochester, Minnesota, United States, 55905
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium    
      Omaha, Nebraska, United States, 68106
United States, North Dakota
Altru Cancer Center    
      Grand Forks, North Dakota, United States, 58201
CCOP - Merit Care Hospital    
      Fargo, North Dakota, United States, 58122
United States, Ohio
CCOP - Toledo Community Hospital    
      Toledo, Ohio, United States, 43623-3456
United States, Oklahoma
CCOP - Oklahoma    
      Tulsa, Oklahoma, United States, 74136
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, 57104
Rapid City Regional Hospital    
      Rapid City, South Dakota, United States, 57709

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

Investigators
Study Chair:     David P. Steensma, MD     Mayo Clinic    
  More Information


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

Publications of Results:
Steensma DP, Molina R, Sloan JA, Nikcevich DA, Schaefer PL, Rowland KM Jr, Dentchev T, Novotny PJ, Tschetter LK, Alberts SR, Hogan TF, Law A, Loprinzi CL. Phase III study of two different dosing schedules of erythropoietin in anemic patients with cancer. J Clin Oncol. 2006 Mar 1;24(7):1079-89.
 
Steensma DP, Molina R, Sloan JA, et al.: A phase III randomized trial of two different dosing schedules of erythropoietin (EPO) in patients with cancer-associated anemia: North Central Cancer Treatment Group (NCCTG) study N02C2. [Abstract] J Clin Oncol 23 (Suppl 16): A-8031, 736s, 2005.
 

Study ID Numbers:   CDR0000288821, NCCTG-N02C2
First Received:   April 7, 2003
Last Updated:   November 16, 2008
ClinicalTrials.gov Identifier:   NCT00058331
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
anemia  
unspecified adult solid tumor, protocol specific  
monoclonal gammopathy of undetermined significance  
primary systemic amyloidosis  
isolated plasmacytoma of bone  
extramedullary plasmacytoma  
refractory multiple myeloma  
Waldenstrom macroglobulinemia  
stage I multiple myeloma  
stage II multiple myeloma  
stage III multiple myeloma  
refractory chronic lymphocytic leukemia  
stage I chronic lymphocytic leukemia  
stage II chronic lymphocytic leukemia  
stage III chronic lymphocytic leukemia  
stage IV chronic lymphocytic leukemia
recurrent adult acute lymphoblastic leukemia
adult acute lymphoblastic leukemia in remission
untreated adult acute lymphoblastic leukemia
prolymphocytic leukemia
T-cell large granular lymphocyte leukemia
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
refractory hairy cell leukemia
untreated hairy cell leukemia
recurrent adult Hodgkin lymphoma
stage I 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
Lymphoma, Large-Cell, Anaplastic
Hodgkin Disease
Chronic lymphocytic leukemia
Lymphoma, Large B-Cell, Diffuse
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Hematologic Diseases
Leukemia, B-cell, chronic
Blood Coagulation Disorders
Multiple Myeloma
Waldenstrom Macroglobulinemia
Plasmacytoma
B-cell lymphomas
Leukemia, T-Cell
Anaplastic large cell lymphoma
Leukemia, B-Cell
Lymphoma, Non-Hodgkin
Hairy cell leukemia
Monoclonal gammopathy of undetermined significance
Lymphoma, T-Cell, Cutaneous

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 November 20, 2008




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