Clinical Trial: Epoetin Alfa in Treating Patients With Anemia Who Are Undergoing Chemotherapy for Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
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 Summary:
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.
Sponsor: Jonsson Comprehensive Cancer Center
Current Primary Outcome:
- Efficacy [ Time Frame: 7 weeks ]
- Safety [ Time Frame: 7 weeks ]
Original Primary Outcome:
Current Secondary Outcome: Quality of life [ Time Frame: 7 weeks ]
Original Secondary Outcome:
Information By: Jonsson Comprehensive Cancer Center
Dates:
Date Received: November 18, 2005
Date Started: August 2005
Date Completion:
Last Updated: October 3, 2012
Last Verified: October 2012