A Phase III, Randomized Study Of Two Different Dosing Schedules Of Erythropoetin In Anemic Patients With Cancer
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 365
- Locations
- 18
- Primary Endpoint
- Compare the effects of these regimens on increasing hemoglobin levels
Study Overview
Brief Summary
RATIONALE: Epoetin alfa may stimulate red blood cell production and treat anemia in patients with solid tumors. It is not yet known whether epoetin alfa given once a week is more effective than epoetin alfa given once every 3 weeks in treating anemia.
PURPOSE: Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients who have solid tumors.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •18 and over
- •Performance status
- •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)
- •No history of pulmonary embolism within the past year (unless on anticoagulation)
- •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
- •More than 14 days since prior major surgery
- •More than 2 weeks since prior red blood cell transfusions
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: epoetin alfa (Biological)
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.
Intervention: epoetin alfa (Biological)
Outcomes
Primary Outcomes
Compare the effects of these regimens on increasing hemoglobin levels
Time Frame: Up to 1 year post-treatment
Secondary Outcomes
- Compare the effects of anemia-specific components of QOL(Up to 1 year post-treatment)
- Compare the effects of these regimens on overall quality of life (QOL)(Up to 1 year post-treatment)