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Epoetin Alfa in Treating Anemia in Patients With Solid Tumors

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ClinicalTrials.gov Identifier: NCT00058331
Recruitment Status : Completed
First Posted : April 9, 2003
Last Update Posted : July 18, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Description
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Brief Summary:

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 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 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 365 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Phase III, Randomized Study Of Two Different Dosing Schedules Of Erythropoetin In Anemic Patients With Cancer
Study Start Date : June 2003
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arms and Interventions
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Arm Intervention/treatment
Experimental: epoetin alfa - long term dosing

Patients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. Then patients receive EPO SC once weekly for 18 weeks. Quality of life is assessed at randomization at then monthly during study treatment.

Patients are followed every 6 months for 1 year.

 Biological: epoetin alfa
Experimental: epoetin alfa - short term dosing

Patients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. 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.

 Biological: epoetin alfa


Outcome Measures
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Primary Outcome Measures :
  1. Compare the effects of these regimens on increasing hemoglobin levels [ Time Frame: Up to 1 year post-treatment ]

Secondary Outcome Measures :
  1. Compare the effects of these regimens on overall quality of life (QOL) [ Time Frame: Up to 1 year post-treatment ]
  2. Compare the effects of anemia-specific components of QOL [ Time Frame: Up to 1 year post-treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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

Surgery

  • More than 14 days since prior major surgery

Other

  • More than 2 weeks since prior red blood cell transfusions
Contacts and Locations
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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): NCT00058331


Locations
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Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: David P. Steensma, MD Dana-Farber Cancer Institute
More Information
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Publications of Results:
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.

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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00058331    
Other Study ID Numbers: NCCTG-N02C2
CDR0000288821 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: April 9, 2003    Key Record Dates
Last Update Posted: July 18, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Precancerous Conditions
Anemia
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
 Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Immunoproliferative Disorders
Immune System Diseases
Lymphatic Diseases
Epoetin Alfa
Hematinics