Epoetin Alfa in Treating Anemia in Patients With Solid Tumors
NCT ID: NCT00058331
Last Updated: 2016-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
365 participants
INTERVENTIONAL
2003-06-30
2006-05-31
Brief Summary
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PURPOSE: Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients who have solid tumors.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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epoetin alfa - long term dosing
Patients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. Then patients receive EPO SC once weekly for 18 weeks. Quality of life is assessed at randomization at then monthly during study treatment.
Patients are followed every 6 months for 1 year.
epoetin alfa
epoetin alfa - short term dosing
Patients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. 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.
epoetin alfa
Interventions
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epoetin alfa
Eligibility Criteria
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Inclusion Criteria
* 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
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
Surgery
* More than 14 days since prior major surgery
Other
* More than 2 weeks since prior red blood cell transfusions
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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David P. Steensma, MD
Role: STUDY_CHAIR
Dana-Farber Cancer Institute
Locations
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CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States
Mayo Clinic
Jacksonville, Florida, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
Siouxland Hematology-Oncology
Sioux City, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
CCOP - Duluth
Duluth, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, United States
Altru Cancer Center
Grand Forks, North Dakota, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, United States
CCOP - Oklahoma
Tulsa, Oklahoma, United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States
Countries
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References
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Steensma DP, Molina R, Sloan JA, Nikcevich DA, Schaefer PL, Rowland KM Jr, Dentchev T, Novotny PJ, Tschetter LK, Alberts SR, Hogan TF, Law A, Loprinzi CL. Phase III study of two different dosing schedules of erythropoietin in anemic patients with cancer. J Clin Oncol. 2006 Mar 1;24(7):1079-89. doi: 10.1200/JCO.2005.02.7276.
Steensma DP, Molina R, Sloan JA, et al.: A phase III randomized trial of two different dosing schedules of erythropoietin (EPO) in patients with cancer-associated anemia: North Central Cancer Treatment Group (NCCTG) study N02C2. [Abstract] J Clin Oncol 23 (Suppl 16): A-8031, 736s, 2005.
Other Identifiers
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CDR0000288821
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCCTG-N02C2
Identifier Type: -
Identifier Source: org_study_id
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