Trials / Completed
CompletedNCT00058331
Epoetin Alfa in Treating Anemia in Patients With Solid Tumors
A Phase III, Randomized Study Of Two Different Dosing Schedules Of Erythropoetin In Anemic Patients With Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 365 (actual)
- Sponsor
- Alliance for Clinical Trials in Oncology · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Anemia
- Leukemia
- Lymphoma
- Lymphoproliferative Disorder
- Multiple Myeloma and Plasma Cell Neoplasm
- Precancerous Condition
- Unspecified Adult Solid Tumor, Protocol Specific
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | epoetin alfa |
Timeline
- Start date
- 2003-06-01
- Primary completion
- 2006-05-01
- Completion
- 2006-05-01
- First posted
- 2003-04-09
- Last updated
- 2016-07-18
Locations
18 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00058331. Inclusion in this directory is not an endorsement.