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A Phase III Randomized Double-Blind Study of Erythropoietin Versus Placebo in Anemic Patients With Cancer Undergoing Chemotherapy


Phase 3
18 Years
N/A
Not Enrolling
Both
Anemia, Breast Cancer, Chronic Myeloproliferative Disorders, Drug/Agent Toxicity by Tissue/Organ, Leukemia, Lung Cancer, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Precancerous Condition, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase III Randomized Double-Blind Study of Erythropoietin Versus Placebo in Anemic Patients With Cancer Undergoing Chemotherapy


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.

PROJECTED ACCRUAL: There will be 300 patients (150 patients per arm) accrued into this study
over 11 months.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Principal Investigator

Thomas E. Witzig, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000066673

NCT ID:

NCT00003600

Start Date:

December 1998

Completion Date:

Related Keywords:

  • Anemia
  • Breast Cancer
  • Chronic Myeloproliferative Disorders
  • Drug/Agent Toxicity by Tissue/Organ
  • Leukemia
  • Lung Cancer
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Precancerous Condition
  • Small Intestine Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • stage IV breast cancer
  • stage IIIA breast cancer
  • recurrent breast cancer
  • monoclonal gammopathy of undetermined significance
  • stage IIIB breast cancer
  • recurrent non-small cell lung cancer
  • recurrent adult Hodgkin lymphoma
  • stage III cutaneous T-cell non-Hodgkin lymphoma
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • isolated plasmacytoma of bone
  • extramedullary plasmacytoma
  • refractory multiple myeloma
  • Waldenström macroglobulinemia
  • stage III multiple myeloma
  • extensive stage small cell lung cancer
  • recurrent small cell lung cancer
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • recurrent adult acute myeloid leukemia
  • relapsing chronic myelogenous leukemia
  • refractory chronic lymphocytic leukemia
  • small intestine lymphoma
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • unspecified adult solid tumor, protocol specific
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • meningeal chronic myelogenous leukemia
  • untreated adult acute myeloid leukemia
  • adult acute myeloid leukemia in remission
  • polycythemia vera
  • primary myelofibrosis
  • essential thrombocythemia
  • untreated hairy cell leukemia
  • progressive hairy cell leukemia, initial treatment
  • refractory hairy cell leukemia
  • chronic myelomonocytic leukemia
  • T-cell large granular lymphocyte leukemia
  • pulmonary carcinoid tumor
  • acute undifferentiated leukemia
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult Burkitt lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • stage III adult T-cell leukemia/lymphoma
  • stage IV adult T-cell leukemia/lymphoma
  • recurrent adult T-cell leukemia/lymphoma
  • secondary acute myeloid leukemia
  • primary central nervous system non-Hodgkin lymphoma
  • anemia
  • drug/agent toxicity by tissue/organ
  • prolymphocytic leukemia
  • AIDS-related peripheral/systemic lymphoma
  • AIDS-related primary CNS lymphoma
  • primary systemic amyloidosis
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • anaplastic large cell lymphoma
  • stage III mycosis fungoides/Sezary syndrome
  • stage IV mycosis fungoides/Sezary syndrome
  • recurrent mycosis fungoides/Sezary syndrome
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Anemia
  • Breast Neoplasms
  • Neoplasms
  • Leukemia
  • Lung Neoplasms
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myeloproliferative Disorders
  • Precancerous Conditions
  • Lymphoma, Large-Cell, Immunoblastic
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Intestinal Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - OchsnerNew Orleans, Louisiana  70121
CentraCare ClinicSaint Cloud, Minnesota  56303
CCOP - Merit Care HospitalFargo, North Dakota  58122
Altru Health SystemsGrand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Medcenter One Health SystemBismarck, North Dakota  58501
Howard University Cancer CenterWashington, District of Columbia  20060