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A Phase III Clinical Trial of PROCRIT (Epoetin Alfa) Versus Placebo in Women Undergoing Adjuvant Chemotherapy for Stage I, II or III Breast Cancer

Primary Purpose

Anemia, Breast Neoplasms, Hemoglobins

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
epoetin alfa
Sponsored by
Ortho Biotech Products, L.P.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Anemia, Breast cancer, Hemoglobin, Quality of Life, Adjuvant Chemotherapy, Pure red cell aplasia (PRCA), Cognitive and executive function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Histologic diagnosis of Stage I, II or III cancer (chemotherapy naïve for breast cancer) with anthracycline-based adjuvant chemotherapy with or without a taxane Hemoglobin >=9 and <=14 g/dL unrelated to transfusion Able to read, understand and complete QoL & Cognition tools Patients with reproductive potential must have a negative serum pregnancy test within 7 days of study enrollment and use an adequate contraceptive method Exclusion Criteria: Patients who will receive more than a total of 24 weeks of chemotherapy psychiatric or neurologic condition that would prevent informed consent and completion of questionnaires or that is poorly controlled with the current treatment regimen severe hemiparesis or other condition, distal neuropathy, action tremor or other motor dysfunction, visual deficiencies preventing/decrease bimanual keyboard operation severe bradyphrenia (slow thinking) or bradykinesia (slow movement)

Sites / Locations

    Outcomes

    Primary Outcome Measures

    To assess the effect of PROCRIT® on impairment of cognitive and executive function

    Secondary Outcome Measures

    To assess the effect of PROCRIT® on severe fatigue, quality of life and mood. Hemoglobin (Hg) Responders were those patients who did not require transfusion during the treatment phase and who demonstrated a > or = 2 g/dL increase in Hg or Hg of 12 g/dL.

    Full Information

    First Posted
    October 28, 2005
    Last Updated
    May 17, 2011
    Sponsor
    Ortho Biotech Products, L.P.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00246597
    Brief Title
    A Phase III Clinical Trial of PROCRIT (Epoetin Alfa) Versus Placebo in Women Undergoing Adjuvant Chemotherapy for Stage I, II or III Breast Cancer
    Official Title
    A Phase III Clinical Trial of PROCRIT (Epoetin Alfa) Versus Placebo in Women Undergoing Adjuvant Chemotherapy for Stage I, II or III Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2010
    Overall Recruitment Status
    Terminated
    Why Stopped
    Study stopped to avoid treating enrolled subjects to hemoglobin levels higher than those specified in current labeling.
    Study Start Date
    December 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Ortho Biotech Products, L.P.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether it is possible to measure temporary difficulty with thinking and/or short-term memory in women who are receiving chemotherapy for early stage breast cancer and to determine whether or not treatment with PROCRIT® will help decrease any problems with thinking or short-term memory that chemotherapy may cause.
    Detailed Description
    Studies of the effect of erythropoietin on rat and mouse brain suggests a neuroprotective and cognitive-enhancing effect of this hormone. The objective of this study was to quantify and compare the incidence of chemotherapy-related impairment of cognitive and executive function in breast cancer patients randomized to receive PROCRIT versus placebo while receiving adjuvant anthracycline-based chemotherapy with or without a Taxane and to evaluate the effect of PROCRIT® on the incidence of asthenia (severe fatigue), quality of life (QoL), and mood. Patients received study medication injections (40,000 units) under their skin once every week for 12 to 24 weeks of chemotherapy. Doses were adjusted depending on the patients' hemoglobin level up to a maximum of 60,000 units.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anemia, Breast Neoplasms, Hemoglobins, Quality of Life, Chemotherapy, Adjuvant
    Keywords
    Anemia, Breast cancer, Hemoglobin, Quality of Life, Adjuvant Chemotherapy, Pure red cell aplasia (PRCA), Cognitive and executive function

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    37 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    epoetin alfa
    Primary Outcome Measure Information:
    Title
    To assess the effect of PROCRIT® on impairment of cognitive and executive function
    Secondary Outcome Measure Information:
    Title
    To assess the effect of PROCRIT® on severe fatigue, quality of life and mood. Hemoglobin (Hg) Responders were those patients who did not require transfusion during the treatment phase and who demonstrated a > or = 2 g/dL increase in Hg or Hg of 12 g/dL.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histologic diagnosis of Stage I, II or III cancer (chemotherapy naïve for breast cancer) with anthracycline-based adjuvant chemotherapy with or without a taxane Hemoglobin >=9 and <=14 g/dL unrelated to transfusion Able to read, understand and complete QoL & Cognition tools Patients with reproductive potential must have a negative serum pregnancy test within 7 days of study enrollment and use an adequate contraceptive method Exclusion Criteria: Patients who will receive more than a total of 24 weeks of chemotherapy psychiatric or neurologic condition that would prevent informed consent and completion of questionnaires or that is poorly controlled with the current treatment regimen severe hemiparesis or other condition, distal neuropathy, action tremor or other motor dysfunction, visual deficiencies preventing/decrease bimanual keyboard operation severe bradyphrenia (slow thinking) or bradykinesia (slow movement)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ortho Biotech Products, L.P. Clinical Trial
    Organizational Affiliation
    Ortho Biotech Products, L.P.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=921&filename=CR002305_CSR.pdf
    Description
    A Phase III Clinical Trial of PROCRIT� (Epoetin alfa) versus Placebo in Women Undergoing Adjuvant Chemotherapy for Stage I, II or III Breast Cancer

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    A Phase III Clinical Trial of PROCRIT (Epoetin Alfa) Versus Placebo in Women Undergoing Adjuvant Chemotherapy for Stage I, II or III Breast Cancer

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