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A Study of PROCRIT (Epoetin Alfa) 80,000 Units (U) Once Every Four Weeks (Q4W) vs. 40,000 U Once Every Two Weeks (Q2W) in Cancer Patients Not Receiving Chemotherapy

Primary Purpose

Anemia, Cancer, Epoetin Alfa

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
epoetin alfa
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Anemia, non-chemotherapy-induced, non-radiation therapy-induced, cancer, non-myeloid

Eligibility Criteria

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

Inclusion Criteria: Patients must have "Active non-myeloid cancer malignancy" or incurable cancer with a life expectancy of 6 months or more Patients may also have had cancer treatment within the past 2 years but no chemotherapy or radiation therapy within the past 8 weeks prior to enrollment must be >= 18 years of age and must not be receiving or planning to receive cytotoxic chemotherapy or external beam radiotherapy during the study period must have a baseline Hb <= 11 g/dL. Patients with reproductive potential must be practicing an effective method of birth control and women cannot be pregnant or breast-feeding during the study period Patients must be able to comply with all requirements of the study (i.e. study visit schedules) and patients (or their legally authorized representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study Exclusion Criteria: Patients receiving or planning to receive chemotherapy or radiation therapy within 8 weeks of study entry Anemia due to factors other than cancer Previous treatment with epoetin alfa or any form of erythropoietin during the previous 1 month or received an experimental drug or device within past 30 days Known hypersensitivity to mammalian-cell derived products or to human albumin Untreated known central nervous system (CNS) metastases Uncontrolled or clinically severe disease of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying malignancy or chemotherapy History of (within 12 months) deep venous thrombosis (DVT), pulmonary embolus (PE), or other venous thrombotic events, cerebrovascular accident (CVA), transient ischemic attack (TIA), Acute Coronary Syndrome (ACS) [unstable angina, myocardial infarction (MI)], or other arterial thrombosis Currently receiving therapeutic or prophylactic anticoagulants Transfusion of packed red blood cells within 28 days prior to the first dose of study drug, or planned stem cell harvest of bone marrow or high dose chemotherapy with stem cell transplant during study duration.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The primary efficacy endpoint will be hematopoietic response, defined as >= 1 g/dL rise in hemoglobin from baseline.

    Secondary Outcome Measures

    Secondary objectives are to assess the two dosing regimens on time-to-hematopoietic response and transfusion requirements. Safety assessments will include laboratory tests, blood pressure, physical examination and severity of adverse events.

    Full Information

    First Posted
    March 21, 2006
    Last Updated
    May 17, 2011
    Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Collaborators
    Ortho Biotech Products, L.P.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00306267
    Brief Title
    A Study of PROCRIT (Epoetin Alfa) 80,000 Units (U) Once Every Four Weeks (Q4W) vs. 40,000 U Once Every Two Weeks (Q2W) in Cancer Patients Not Receiving Chemotherapy
    Official Title
    A Pilot Study to Evaluate the Safety and Efficacy of PROCRIT (Epoetin Alfa) 80,000 Units Once Every Four Weeks (Q4W) vs. 40,000 Units Once Every Two Weeks (Q2W) in Cancer Subjects With Non-Chemotherapy Anemia (NCA)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2010
    Overall Recruitment Status
    Terminated
    Why Stopped
    Study stopped as it would not address important survival concerns raised in other recently conducted clinical studies.
    Study Start Date
    March 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    May 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Collaborators
    Ortho Biotech Products, L.P.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to assess the safety and effectiveness of PROCRIT (Epoetin alfa) administered by injection subcutaneously (SC, under the skin), at a dose of 80,000 U once every four weeks or 40,000 U once every two in anemic patients with cancer not receiving chemotherapy or radiation therapy.
    Detailed Description
    Epoetin alfa is an analogue (has the identical amino acid sequence) of erythropoetin, a hormone secreted by kidneys known to stimulate red blood cell production. Although epoetin alfa has been known to be effective in treatment of anemia associated with cancer chemotherapy, there are no specific formal guidelines on the use of epoetin alfa for the treatment of anemia in cancer patients not receiving chemotherapy or radiation therapy. Several prospective clinical trials investigating the efficacy of epoetin alfa in cancer-associated anemia included groups of patients not receiving chemotherapy where it was demonstrated that the use of epoetin alfa in this population was safe and effective in increasing hemoglobin (Hb) levels and reducing transfusion requirements. The optimal dosing regimen of epoetin alfa in cancer patients not receiving chemotherapy or radiation therapy remains unclear. This 17-week study is a prospective, randomized, open-label, multi-center study to assess the safety and effectiveness of epoetin alfa in anemic patients with cancer not receiving chemotherapy or radiation therapy. Eligible patients with hemoglobin level <= 11 g/dL will receive epoetin alfa 40,000 U once every 2 weeks for 15 weeks or 80,000 U once every 4 weeks for 13 weeks. The study hypothesis are that there are no long-term safety concerns of epoetin alfa administered at these two dosing regimens and that both dosing regimens are equally effective in this patient population. Eligible patients with hemoglobin levels <= 11 g/dL will receive epoetin alfa 40,000 U once every 2 weeks for 15 weeks or 80,000 U once every 4 weeks for 13 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anemia, Cancer, Epoetin Alfa
    Keywords
    Anemia, non-chemotherapy-induced, non-radiation therapy-induced, cancer, non-myeloid

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    61 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    epoetin alfa
    Primary Outcome Measure Information:
    Title
    The primary efficacy endpoint will be hematopoietic response, defined as >= 1 g/dL rise in hemoglobin from baseline.
    Secondary Outcome Measure Information:
    Title
    Secondary objectives are to assess the two dosing regimens on time-to-hematopoietic response and transfusion requirements. Safety assessments will include laboratory tests, blood pressure, physical examination and severity of adverse events.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients must have "Active non-myeloid cancer malignancy" or incurable cancer with a life expectancy of 6 months or more Patients may also have had cancer treatment within the past 2 years but no chemotherapy or radiation therapy within the past 8 weeks prior to enrollment must be >= 18 years of age and must not be receiving or planning to receive cytotoxic chemotherapy or external beam radiotherapy during the study period must have a baseline Hb <= 11 g/dL. Patients with reproductive potential must be practicing an effective method of birth control and women cannot be pregnant or breast-feeding during the study period Patients must be able to comply with all requirements of the study (i.e. study visit schedules) and patients (or their legally authorized representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study Exclusion Criteria: Patients receiving or planning to receive chemotherapy or radiation therapy within 8 weeks of study entry Anemia due to factors other than cancer Previous treatment with epoetin alfa or any form of erythropoietin during the previous 1 month or received an experimental drug or device within past 30 days Known hypersensitivity to mammalian-cell derived products or to human albumin Untreated known central nervous system (CNS) metastases Uncontrolled or clinically severe disease of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying malignancy or chemotherapy History of (within 12 months) deep venous thrombosis (DVT), pulmonary embolus (PE), or other venous thrombotic events, cerebrovascular accident (CVA), transient ischemic attack (TIA), Acute Coronary Syndrome (ACS) [unstable angina, myocardial infarction (MI)], or other arterial thrombosis Currently receiving therapeutic or prophylactic anticoagulants Transfusion of packed red blood cells within 28 days prior to the first dose of study drug, or planned stem cell harvest of bone marrow or high dose chemotherapy with stem cell transplant during study duration.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
    Organizational Affiliation
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=716&filename=CR010540_CSR.pdf
    Description
    A Pilot Study to Evaluate the Safety and Efficacy of PROCRIT� (epoetin alfa) 80,000 Units Once Every 4 Weeks (q4w) vs. 40,000 Units Once Every 2 Weeks (q2w) in Cancer Subjects With Non-Chemotherapy Anemia (NCA)

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    A Study of PROCRIT (Epoetin Alfa) 80,000 Units (U) Once Every Four Weeks (Q4W) vs. 40,000 U Once Every Two Weeks (Q2W) in Cancer Patients Not Receiving Chemotherapy

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