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

October 3, 2012 updated by: Jonsson Comprehensive Cancer Center

Assessment of Early and Standard Intervention With Procrit® (Epoetin Alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients With Cancer Receiving Chemotherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

89

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed nonmyeloid cancer

    • No history of myelodysplasia
  • Baseline hemoglobin 11-12 g/dL
  • No anemia due to factors other than cancer or chemotherapy (e.g., iron, cyanocobalamin [vitamin B_12], or folate deficiencies, hemolysis, or gastrointestinal bleeding)

  • Receiving chemotherapy that meets the following criteria:

    • Administered weekly OR every 3 weeks
    • Must begin chemotherapy on or before the first day of study treatment
  • No known, untreated CNS metastases

PATIENT CHARACTERISTICS:

Performance status

  • ECOG 0-2

Life expectancy

  • At least 6 months

Hematopoietic

  • See Disease Characteristics
  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3 (transfusion independent)
  • Iron transferrin saturation > 20%
  • No history of chronic hypercoagulable disorders (e.g., activated protein C resistance, anti-cardiolipin disorder, protein C deficiency, or protein S deficiency)

Hepatic

  • Bilirubin < 2.0 mg/dL
  • SGPT ≤ 3 times upper limit of normal

Renal

  • Creatinine ≤ 1.5 mg/dL
  • No significant, uncontrolled genitourinary disease or dysfunction

Cardiovascular

  • No uncontrolled cardiac arrhythmia in the past 6 months
  • No uncontrolled hypertension

  • No deep vein thrombosis, ischemic stroke, or other arterial or venous thrombotic events

    • Superficial thromboses allowed
  • No other significant, uncontrolled cardiovascular disease or dysfunction

Pulmonary

  • No significant, uncontrolled pulmonary disease or dysfunction
  • No pulmonary emboli

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No infection requiring hospitalization or antibiotics in the past 14 days
  • No known hypersensitivity to mammalian cell-derived products or to human albumin
  • No new onset (in the past 3 months) poorly controlled seizures
  • No other active malignancy except basal cell carcinoma or carcinoma in situ
  • Not an employee of the investigator or study center or family members of the employee or the investigator
  • No significant, uncontrolled neurological, endocrine, or gastrointestinal disease or dysfunction

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Chemotherapy
  • More than 3 months since prior erythropoietic agent (e.g., epoetin alfa, darbepoetin alfa, or gene-activated erythropoietin)
  • More than 4 weeks since prior packed red blood cell transfusion
  • No concurrent stem cell harvest of bone marrow
  • No concurrent interleukin-11
  • No other concurrent erythropoietic agent

Chemotherapy

  • See Disease Characteristics
  • No concurrent high-dose chemotherapy with stem cell transplantation

Radiotherapy

  • No concurrent nonpalliative radiotherapy

Surgery

  • More than 2 weeks since prior major surgery

Other

  • At least 1 month since prior investigational agents or devices
  • No concurrent high-dose IV iron supplementation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy
Time Frame: 7 weeks
7 weeks
Safety
Time Frame: 7 weeks
7 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: 7 weeks
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: John A. Glaspy, MD, MPH, Jonsson Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

November 18, 2005

First Submitted That Met QC Criteria

November 18, 2005

First Posted (Estimate)

November 21, 2005

Study Record Updates

Last Update Posted (Estimate)

October 4, 2012

Last Update Submitted That Met QC Criteria

October 3, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000449950
  • UCLA-0504038
  • ORTHO-PR04-27-018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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