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

Not Applicable

Terminated

Conditions: Fatigue
Unspecified Adult Solid Tumor, Protocol Specific
Anemia

Interventions: Drug: Weekly procrit dosing
Drug: Interval Dosing

Registration Number: NCT00258440

Lead Sponsor: OHSU Knight Cancer Institute

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. It may also help relieve fatigue in patients with anemia.

PURPOSE: This randomized clinical 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 treating patients with anemia undergoing chemotherapy for nonhematologic cancer.

Secondary

* Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.

* Correlate hemoglobin and hematocrit response with patient age (\> 65 years vs \< 65 years) in patients treated with this drug.

* Determine quality of life of patients treated with this drug.

* Determine the adverse effects of this drug in these patients.

* Determine the change over time of symptom and quality of life variables (e.g., fatigue) in patients treated with this drug.

OUTLINE: This is a partially randomized, pilot study. Patients are stratified according to age (\< 65 years vs ≥ 65 years). Patients are assigned to 1 of 2 treatment groups based on participation in the pharmacokinetic (PK) portion of the study.

* Group 1 (PK study, initial therapy): Patients are randomized to 1 of 2 treatment arms.

* Arm I: Five patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity.

* Arm II: Five patients receive epoetin alfa SC once weekly until hematocrit is \> 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy.

Patients in both arms also undergo PK sampling periodically during study treatment.

* Group 2 (non-PK study, initial therapy): Fifteen patients receive epoetin alfa SC once weekly until hematocrit is \> 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy.

* Maintenance therapy: Patients receive epoetin alfa SC once every other week for up to 24 weeks of total treatment (including both initial therapy and maintenance therapy). Patients whose blood counts fall below the critical levels are placed on a weekly dosing schedule. Patients whose blood counts rise too high discontinue study drug until blood counts are reduced.

Quality of life (including fatigue) is assessed at baseline and then every 4 weeks for 28 weeks.

After completion of study therapy, patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weekly Procrit (epoetin alfa) dosing	Weekly procrit dosing	Weekly dosing schedule subjects will get the study drug once every week until the end of the study.
Interval Dosing (epoetin alfa) Non PK Group	Interval Dosing	Interval-dosing schedule subjects will get the study drug once every week until hematocrit is greater than 36% or Hemoglobin reaches a value of 12 g/dl, then they will get study drug once every other week. Subjects who did not consent to pharmacokinetic testing.
Interval Dosing (epoetin alfa) PK Group	Interval Dosing	Interval-dosing schedule subjects will get the study drug once every week until hematocrit is greater than 36% or Hemoglobin reaches a value of 12 g/dl, then they will get study drug once every other week. Subjects who consented to pharmacokinetic testing

Primary Outcome Measures

Name	Time	Method
Number of Subjects That Maintained Target Hemoglobin Level (11-12 g/dL) Maintenance Weekly for 12 Weeks	12 weeks

Secondary Outcome Measures

Name	Time	Method
Number of Adverse Events (AEs) Experienced as Measure of Safety and Tolerability.	On study, averaging 3 to 6 months.
Pharmacokinetics (PK) and Pharmacodynamics Assays That Measure Concentration of Erythropoietin in Serum.	every other week
Quality of Life at Baseline and Weeks 4, 8, 16, 24, and 28	weeks 4,8,16,24 and 28