A Phase III, Randomized Study Of Two Different Dosing Schedules Of Erythropoetin In Anemic Patients With Cancer
Phase 3
18 Years
N/A
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
Both
Anemia, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Precancerous Condition, Unspecified Adult Solid Tumor, Protocol Specific
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 Center | Rochester, Minnesota 55905 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
| CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| CCOP - Duluth | Duluth, Minnesota 55805 |
| Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
| CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
| Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
| CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
| CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
| CCOP - Oklahoma | Tulsa, Oklahoma 74136 |
| CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
| Mayo Clinic | Jacksonville, Florida 32224 |
| Altru Cancer Center | Grand Forks, North Dakota 58206 |
| CCOP - Mayo Clinic Scottsdale Oncology Program | Scottsdale, Arizona 85259 |
