A Phase III, Randomized Study Of Two Different Dosing Schedules Of Erythropoetin In Anemic Patients With Cancer
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Anemia
- Sponsor
- Alliance for Clinical Trials in Oncology
- Enrollment
- 365
- Locations
- 18
- Primary Endpoint
- Compare the effects of these regimens on increasing hemoglobin levels
- Status
- Completed
- Last Updated
- 9 years ago
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
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)