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

NCT ID: NCT00258440

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-31
• Study Completion Date: 2008-09-30

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.

Conditions

Anemia; Fatigue; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Weekly Procrit (epoetin alfa) dosing

Weekly dosing schedule subjects will get the study drug once every week until the end of the study.

Group Type: ACTIVE_COMPARATOR

Weekly procrit dosing

Intervention Type: DRUG

The dose is standard of care, the investigational piece is the dosing schedule itself. Either weekly or 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.

Interval Dosing (epoetin alfa) PK Group

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

Group Type: EXPERIMENTAL

Interval Dosing

Intervention Type: DRUG

The dosing of Procrit is standard of care, it is the schedule that is the investigational piece.

Interval Dosing (epoetin alfa) Non PK Group

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.

Group Type: EXPERIMENTAL

Interval Dosing

Intervention Type: DRUG

The dosing of Procrit is standard of care, it is the schedule that is the investigational piece.

Interventions

Weekly procrit dosing

The dose is standard of care, the investigational piece is the dosing schedule itself. Either weekly or 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.

Intervention Type: DRUG

Interval Dosing

The dosing of Procrit is standard of care, it is the schedule that is the investigational piece.

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

• Patient has uncontrolled hypertension
• Patient has history of symptomatic cardiac disease
• Patient has serious intercurrent illness
• The patient is pregnant, has a positive serum HCG or is lactating Patient has known hypersensitivity to mammalian cell-derived products or human albumin.
• Patient has diagnosis of polycythemia vera, chronic myelogenous leukemia, myelodysplastic syndrome
• May not be due for transplant within 24 weeks
• Anemia due to factors other than cancer.
• History of a thrombotic vascular event.
• History of seizures
• Patient has received a red blood cell growth factor (epoetin alfa or darbepoetin) within the last 60 days

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ortho Biotech, Inc.

INDUSTRY

Sponsor Role: collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Joseph Bubalo

PharmD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph Bubalo, PharmD, BCPS, BCOP

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

OHSU Knight Cancer Institute

Portland, Oregon, United States

Countries

United States

Other Identifiers

OHSU-ONC-03017-LP

Identifier Type: OTHER

Identifier Source: secondary_id

OHSU-1616

Identifier Type: OTHER

Identifier Source: secondary_id

OHSU-7754

Identifier Type: OTHER

Identifier Source: secondary_id

ORTHO-ONC-03017-LP

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000445450

Identifier Type: -

Identifier Source: org_study_id