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Epoetin Alfa in Treating Anemia in Patients With Solid Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00058331
First Posted: April 9, 2003
Last Update Posted: July 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
April 7, 2003
April 9, 2003
July 18, 2016
June 2003
May 2006   (Final data collection date for primary outcome measure)
Compare the effects of these regimens on increasing hemoglobin levels [ Time Frame: Up to 1 year post-treatment ]
Not Provided
Complete list of historical versions of study NCT00058331 on ClinicalTrials.gov Archive Site
  • Compare the effects of these regimens on overall quality of life (QOL) [ Time Frame: Up to 1 year post-treatment ]
  • Compare the effects of anemia-specific components of QOL [ Time Frame: Up to 1 year post-treatment ]
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Not Provided
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Epoetin Alfa in Treating Anemia in Patients With Solid Tumors
A Phase III, Randomized Study Of Two Different Dosing Schedules Of Erythropoetin In Anemic Patients With Cancer

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Anemia
  • Leukemia
  • Lymphoma
  • Lymphoproliferative Disorder
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Precancerous Condition
  • Unspecified Adult Solid Tumor, Protocol Specific
Biological: epoetin alfa
  • 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.

    Intervention: 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.

    Intervention: Biological: epoetin alfa

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
365
May 2006
May 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00058331
NCCTG-N02C2
CDR0000288821 ( Registry Identifier: PDQ (Physician Data Query) )
Yes
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: David P. Steensma, MD Dana-Farber Cancer Institute
Alliance for Clinical Trials in Oncology
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP