Epoetin Alfa in Treating Anemia in Patients Who Are Receiving Chemotherapy

Last updated: July 12, 2016
Sponsor: Alliance for Clinical Trials in Oncology
Overall Status: Completed

Phase

3

Condition

Lung Disease

Anemia

Lung Cancer

Treatment

N/A

Clinical Study ID

NCT00003600
NCCTG-979253
CDR0000066673
NCI-P98-0133
  • Ages > 18
  • All Genders

Study Summary

RATIONALE: Epoetin alfa may stimulate red blood cell production and treat anemia in patients with cancer who are receiving chemotherapy. It is not yet known whether epoetin alfa is more effective than a placebo in treating anemia in patients receiving chemotherapy.

PURPOSE: Randomized double blinded phase III trial to compare the effectiveness of epoetin alfa with a placebo in treating anemia in cancer patients who are receiving chemotherapy.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS: Anemic: Hemoglobin in males less than 11.5 g/dL; hemoglobin in females less than 10.0 g/dL No anemia secondary to B12, folic acid, or iron deficiency No anemia secondary to gastrointestinal bleed or hemolysis No anemia secondary to a primary or chemotherapy-induced myelodysplastic syndrome No anemia secondary to acute lymphocytic leukemia Histologically confirmed advanced malignancy Lung Breast Other Currently receiving myelosuppressive, cytotoxic chemotherapy for advanced cancer No patients receiving adjuvant therapy for cancer that has been surgically removed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 4 months Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified Cardiovascular: No uncontrolled hypertension (systolic at least 180, diastolic at least 100) Other: Normal or elevated ferritin No known hypersensitivity to epoetin alfa Must be able to reliably take oral medication Must be alert and mentally competent Not pregnant or nursing

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 year since prior epoetin alfa At least 2 weeks since prior red blood cell transfusions No concurrent peripheral blood stem cell or bone marrow transplantation Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Concurrent radiotherapy allowed Surgery: See Disease Characteristics

Study Design

Total Participants: 344
Study Start date:
December 01, 1998
Estimated Completion Date:
January 31, 2010

Study Description

OBJECTIVES: I. Determine whether epoetin alfa treatment improves the quality of life in anemic patients who are undergoing chemotherapy for advanced malignancy. II. Determine whether epoetin alfa increases hemoglobin levels and decreases transfusion requirements in these patients. III. Validate or refute the use of an algorithm using pre- and posttreatment epoetin alfa, ferritin, and hemoglobin levels to predict 16 weeks response or no response to therapeutic doses of epoetin alfa as set forth by these patients. IV. Explore whether anemic patients receiving platinum-containing chemotherapy regimens experience less nephrotoxicity if they receive concurrent epoetin alfa compared to those who receive placebo.

OUTLINE: This is a randomized, double blind study. Patients are stratified by primary malignant disease (lung vs breast vs other), life expectancy (4-6 months vs greater than 6 months), planned concurrent radiotherapy (yes vs no), and degree of anemia (mild or at least 9 g/dL vs severe or less than 9 g/dL). Patients receiving chemotherapy are randomized to receive epoetin alfa subcutaneously once a week for a maximum of 16 weeks (arm I) or placebo subcutaneously once a week for a maximum of 16 weeks (arm II). Quality of life is assessed at randomization and monthly throughout study. Patients are followed every 6 months for 1 year.

Connect with a study center

  • Allan Blair Cancer Centre

    Regina, Saskatchewan S4T 7T1
    Canada

    Site Not Available

  • CCOP - Scottsdale Oncology Program

    Scottsdale, Arizona 85259-5404
    United States

    Site Not Available

  • Howard University Cancer Center

    Washington, District of Columbia 20060
    United States

    Site Not Available

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois 61602
    United States

    Site Not Available

  • CCOP - Carle Cancer Center

    Urbana, Illinois 61801
    United States

    Site Not Available

  • CCOP - Cedar Rapids Oncology Project

    Cedar Rapids, Iowa 52403-1206
    United States

    Site Not Available

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa 50309-1016
    United States

    Site Not Available

  • Siouxland Hematology-Oncology

    Sioux City, Iowa 51101-1733
    United States

    Site Not Available

  • CCOP - Wichita

    Wichita, Kansas 67214-3882
    United States

    Site Not Available

  • CCOP - Ochsner

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • CCOP - Duluth

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • Mayo Clinic Cancer Center

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • CentraCare Clinic

    Saint Cloud, Minnesota 56303
    United States

    Site Not Available

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska 68131
    United States

    Site Not Available

  • Medcenter One Health System

    Bismarck, North Dakota 58501
    United States

    Site Not Available

  • CCOP - Merit Care Hospital

    Fargo, North Dakota 58122
    United States

    Site Not Available

  • Altru Health Systems

    Grand Forks, North Dakota 58201
    United States

    Site Not Available

  • CCOP - Toledo Community Hospital Oncology Program

    Toledo, Ohio 43623-3456
    United States

    Site Not Available

  • CCOP - Geisinger Clinic and Medical Center

    Danville, Pennsylvania 17822-2001
    United States

    Site Not Available

  • Rapid City Regional Hospital

    Rapid City, South Dakota 57709
    United States

    Site Not Available

  • CCOP - Sioux Community Cancer Consortium

    Sioux Falls, South Dakota 57105-1080
    United States

    Site Not Available

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