Assessment of Early and Standard Intervention With Procrit® (Epoetin Alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients With Cancer Receiving Chemotherapy
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Anemia
- Sponsor
- Jonsson Comprehensive Cancer Center
- Enrollment
- 89
- Locations
- 1
- Primary Endpoint
- Efficacy
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Detailed Description
OBJECTIVES: Primary * 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. Secondary * 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Efficacy
Time Frame: 7 weeks
Safety
Time Frame: 7 weeks
Secondary Outcomes
- Quality of life(7 weeks)