Trials / Completed
CompletedNCT00255749
Epoetin Alfa in Treating Patients With Anemia Who Are Undergoing Chemotherapy for Cancer
Assessment of Early and Standard Intervention With Procrit® (Epoetin Alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients With Cancer Receiving Chemotherapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 89 (actual)
- Sponsor
- Jonsson Comprehensive Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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
- 2005-08-01
- Primary completion
- 2007-04-01
- First posted
- 2005-11-21
- Last updated
- 2012-10-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00255749. Inclusion in this directory is not an endorsement.