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

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.

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

• 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

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   

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