Epoetin Alfa in Treating Patients With Anemia Who Are Undergoing Chemotherapy for Cancer
RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat anemia caused by cancer and chemotherapy.
PURPOSE: This randomized phase II trial is studying how well epoetin alfa works in treating patients with anemia who are undergoing chemotherapy for cancer.
|Anemia Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Precancerous Condition Unspecified Adult Solid Tumor, Protocol Specific||Biological: epoetin alfa||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
|Official Title:||Assessment of Early and Standard Intervention With Procrit® (Epoetin Alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients With Cancer Receiving Chemotherapy|
- Efficacy [ Time Frame: 7 weeks ]
- Safety [ Time Frame: 7 weeks ]
- Quality of life [ Time Frame: 7 weeks ]
|Study Start Date:||August 2005|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
Experimental: early intervention epoietin alfa
Patients receive epoetin alfa subcutaneously on day 1. Treatment repeats every 21 days for up to 5 courses.
|Biological: epoetin alfa|
standard intervention epoietin alfa
Patients receive epoetin alfa as in arm I once their hemoglobin level is ≤ 10.5 g/dL.
|Biological: epoetin alfa|
- Determine the efficacy, in terms of maintenance of target hemoglobin and hematocrit levels, of interval dosing with epoetin alfa in patients with anemia undergoing chemotherapy for nonmyeloid cancer.
- Determine the safety of this drug in these patients.
- Determine the quality of life of patients treated with this drug.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I (early intervention): Patients receive epoetin alfa subcutaneously on day 1. Treatment repeats every 21 days for up to 5 courses.
- Arm II (standard intervention): Patients receive epoetin alfa as in arm I once their hemoglobin level is ≤ 10.5 g/dL.
Quality of life is assessed prior to start of study treatment, at week 7 during study treatment, and after completion of study treatment.
After completion of study treatment, patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00255749
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|Principal Investigator:||John A. Glaspy, MD, MPH||Jonsson Comprehensive Cancer Center|