Know Cancer

or
forgot password

A Phase III, Randomized Study Of Two Different Dosing Schedules Of Erythropoetin In Anemic Patients With Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Anemia, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Precancerous Condition, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

A Phase III, Randomized Study Of Two Different Dosing Schedules Of Erythropoetin In Anemic Patients With Cancer


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.

Inclusion 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_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

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Principal Investigator

David P. Steensma, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000288821

NCT ID:

NCT00058331

Start Date:

June 2003

Completion Date:

Related Keywords:

  • Anemia
  • Leukemia
  • Lymphoma
  • Lymphoproliferative Disorder
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Precancerous Condition
  • Unspecified Adult Solid Tumor, Protocol Specific
  • anemia
  • unspecified adult solid tumor, protocol specific
  • monoclonal gammopathy of undetermined significance
  • primary systemic amyloidosis
  • isolated plasmacytoma of bone
  • extramedullary plasmacytoma
  • refractory multiple myeloma
  • Waldenström macroglobulinemia
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • refractory chronic lymphocytic leukemia
  • stage I chronic lymphocytic leukemia
  • stage II chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • recurrent adult acute lymphoblastic leukemia
  • adult acute lymphoblastic leukemia in remission
  • untreated adult acute lymphoblastic leukemia
  • prolymphocytic leukemia
  • T-cell large granular lymphocyte leukemia
  • recurrent adult T-cell leukemia/lymphoma
  • stage I adult T-cell leukemia/lymphoma
  • stage II adult T-cell leukemia/lymphoma
  • stage III adult T-cell leukemia/lymphoma
  • stage IV adult T-cell leukemia/lymphoma
  • refractory hairy cell leukemia
  • untreated hairy cell leukemia
  • recurrent adult Hodgkin lymphoma
  • stage I adult Hodgkin lymphoma
  • stage II adult Hodgkin lymphoma
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • anaplastic large cell lymphoma
  • post-transplant lymphoproliferative disorder
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • stage I cutaneous T-cell non-Hodgkin lymphoma
  • stage II cutaneous T-cell non-Hodgkin lymphoma
  • stage III cutaneous T-cell non-Hodgkin lymphoma
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • stage I mycosis fungoides/Sezary syndrome
  • stage II mycosis fungoides/Sezary syndrome
  • stage III mycosis fungoides/Sezary syndrome
  • stage IV mycosis fungoides/Sezary syndrome
  • contiguous stage II adult diffuse mixed cell lymphoma
  • contiguous stage II adult diffuse small cleaved cell lymphoma
  • contiguous stage II adult Burkitt lymphoma
  • contiguous stage II adult immunoblastic large cell lymphoma
  • contiguous stage II adult lymphoblastic lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • contiguous stage II mantle cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • stage I adult diffuse large cell lymphoma
  • stage I adult diffuse mixed cell lymphoma
  • stage I adult diffuse small cleaved cell lymphoma
  • stage I adult Burkitt lymphoma
  • stage I adult immunoblastic large cell lymphoma
  • stage I adult lymphoblastic lymphoma
  • stage I grade 1 follicular lymphoma
  • stage I grade 2 follicular lymphoma
  • stage I grade 3 follicular lymphoma
  • stage I mantle cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult Burkitt lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III mantle cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult Burkitt lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV mantle cell lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage I marginal zone lymphoma
  • stage I small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • contiguous stage II marginal zone lymphoma
  • contiguous stage II small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Anemia
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoproliferative Disorders
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Precancerous Conditions
  • Lymphoma, Large-Cell, Immunoblastic

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 - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
CCOP - DuluthDuluth, Minnesota  55805
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - Merit Care HospitalFargo, North Dakota  58122
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
CCOP - OklahomaTulsa, Oklahoma  74136
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Mayo ClinicJacksonville, Florida  32224
Altru Cancer CenterGrand Forks, North Dakota  58206
CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdale, Arizona  85259