Epoetin Alfa in Treating Patients With Anemia Who Are Undergoing Chemotherapy for Cancer

Phase 2

Completed

• Conditions: Anemia; Leukemia; Lymphoma; Lymphoproliferative Disorder; Multiple Myeloma and Plasma Cell Neoplasm; Precancerous Condition; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Biological: epoetin alfa

• Registration Number: NCT00255749
• Lead Sponsor: Jonsson Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-11-18
• Study First Submitted QC: 2005-11-18
• Study First Posted: 2005-11-21
• Primary Completion: 2007-04
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-03
• Last Update Posted: 2012-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
early intervention epoietin alfa	epoetin alfa	Patients receive epoetin alfa subcutaneously on day 1. Treatment repeats every 21 days for up to 5 courses.
standard intervention epoietin alfa	epoetin alfa	Patients receive epoetin alfa as in arm I once their hemoglobin level is ≤ 10.5 g/dL.

Primary Outcome Measures

Name	Time	Method
Efficacy	7 weeks
Safety	7 weeks

Secondary Outcome Measures

Name	Time	Method
Quality of life	7 weeks

Trial Locations

Locations (1)

Jonsson Comprehensive Cancer Center at UCLA; 🇺🇸 Los Angeles, California, United States