Darbepoetin Alfa Compared With Epoetin Alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer
RATIONALE: Darbepoetin alfa and epoetin alfa may stimulate red blood cell production and treat anemia in patients who are receiving chemotherapy. It is not yet known whether darbepoetin alfa is more effective than epoetin alfa in treating patients with anemia.
PURPOSE: Randomized phase III trial to compare the effectiveness of darbepoetin alfa with that of epoetin alfa in treating anemia in patients who are receiving chemotherapy for cancer.
|Anemia Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Precancerous/Nonmalignant Condition Unspecified Adult Solid Tumor, Protocol Specific||Drug: darbepoetin alfa Drug: epoetin alfa||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
|Official Title:||A Randomized, Open-Label, Multicenter Study Of Darbepoetin Alfa Administered Once Every Two Weeks (Q2W) Compared With rHuEPO Administered Once Every Week (QW) For The Treatment Of Anemia In Subjects With Non-Myeloid Malignancies Receiving Multiple Chemotherapy|
- Compare Efficacy of darbepoetin alfa with Epoetin Alfa as measured by the incidence of red blood cell transfusions. [ Time Frame: 12 weeks ]
|Study Start Date:||August 2003|
|Primary Completion Date:||November 2003 (Final data collection date for primary outcome measure)|
Experimental: Darbepoetin alfa
darbepoetin alfa administered once every two weeks at a dose of 200 ug over a 16 week treatment period.
Drug: darbepoetin alfa
darbepoetin alfa administered at a dose of 200ug once every 2 weeks over a 16-week treatment period
Active Comparator: Epoetin alfa
epoetin alfa administered at 40,000 unites, once per week over a 16-week treatment period.
Drug: epoetin alfa
epoetin alfa administered at a dose of 40,000U once every week over a 16-week treatment period
- Compare the efficacy of darbepoetin alfa vs epoetin alfa for anemia in patients with non-myeloid malignancies receiving chemotherapy.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to screening hemoglobin concentration (less than 10.0 g/dL vs 10.0-11.0 g/dL) and type of concurrent chemotherapy (platinum-based vs non-platinum-based). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive darbepoetin alfa subcutaneously (SC) every other week for 12 weeks (i.e., on weeks 1, 3, 5, 7, 9, and 11).
- Arm II: Patients receive epoetin alfa SC once weekly for 12 weeks. Patients are followed at 1 and 3 weeks .
PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study within 6 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00070382
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||John A. Glaspy, MD, MPH||Jonsson Comprehensive Cancer Center|