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Epoetin alfa in Treating Anemia in Patients With Solid Tumors - Article


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Anemia

General anemia 



Clinical Trial: Epoetin alfa in Treating Anemia in Patients With Solid Tumors

This study is no longer recruiting patients.

Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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

Condition Treatment or Intervention Phase
adult solid tumor
Anemia
Leukemia
Lymphoma
plasma cell neoplasm
 Drug: epoetin alfa
 Procedure: complications of therapy assessment/management
 Procedure: hematologic toxicity attenuation
 Procedure: supportive care/therapy
Phase III

MedlinePlus related topics:  Anemia;   Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphoma;   Multiple Myeloma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Epoetin alfa in Anemic Patients With Nonmyeloid Cancer

Further Study Details: 

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 above,  Genders Eligible for Study:  Both

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
  • , 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

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

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • More than 14 days since prior major surgery

Other


Location Information


Arizona
      CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States

Florida
      Mayo Clinic, Jacksonville,  Florida,  32224,  United States

Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States

      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61602,  United States

Iowa
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States

      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States

Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States

Michigan
      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States

Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States

      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States

Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States

North Dakota
      Altru Cancer Center, Grand Forks,  North Dakota,  58201,  United States

      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States

Ohio
      CCOP - Toledo Community Hospital, Toledo,  Ohio,  43623-3456,  United States

Oklahoma
      CCOP - Oklahoma, Tulsa,  Oklahoma,  74136,  United States

Pennsylvania
      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States

South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States

      Rapid City Regional Hospital, Rapid City,  South Dakota,  57709,  United States

Study chairs or principal investigators

David P. Steensma, MD,  Study Chair,  Mayo Clinic Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000288821; NCCTG-N02C2
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  April 7, 2003
ClinicalTrials.gov Identifier:  NCT00058331
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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April 24, 2014



Page Updated: October 15, 2009
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