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A Study of Subjects With Previously Untreated Extensive-Stage Small-Cell Lung Cancer (SCLC) Treated With Platinum Plus Etoposide Chemotherapy With or Without Darbepoetin Alfa

Primary Purpose

Small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
placebo
darbepoetin alfa
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Oncology, Clinical Trial, Hemoglobin, Darbepoetin alfa, Survival, Carboplatin, Cisplatin, Etoposide, Extensive Stage Small Cell Lung Cancer

Eligibility Criteria

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

Inclusion Criteria: Pathologically proven SCLC, extensive-stage Planned to receive chemotherapy of carboplatin or cisplatin plus etoposide every 3 weeks for 6 cycles Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Life expectancy greater than or equal to 3 months Hemoglobin concentration greater than or equal to 9.0 g/dL and less than or equal to 13g/dL Adequate renal, liver and hematopoietic function Subjects must sign and date a written Institutional Review Board /Independent Ethics Committee-approved Informed Consent Form Exclusion Criteria: Known primary hematologic disorder which could cause anemia Brain metastases that are either symptomatic or treated with medications Unstable or uncontrolled disease/condition, related to or affecting cardiac function Other known primary malignancy within the past 5 years with the exception of curatively treated basal cell carcinoma, squamous cell carcinoma in situ cervical carcinoma or surgically cured malignancies Iron deficiency Known positive test for human immunodeficiency virus infection Received greater than 2 units of packed red blood cells within 4 weeks of randomization or any RBC transfusions within 2 weeks before randomization Received rHuEPO or darbepoetin alfa therapy within 4 weeks of randomization Previous chemotherapy for SCLC Previous radiotherapy except as symptom palliation for bone or brain lesions and at least 24 hours since prior radiotherapy for symptom palliation providing extent of radiotherapy makes marked bone marrow suppression unlikely Less than 30 days since receipt of any drug or device that is not approved for any indication Pregnant or breast-feeding Not using adequate contraceptive precautions Previously randomized into this study Known hypersensitivity to recombinant mammalian-derived product or any other ingredients contained in the study drug Any medical, mental, or other conditions that makes the subject unsuitable for participation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Group 1 - darbepoetin alfa

    Group 2 - Placebo

    Arm Description

    Darbepoetin alfa 300 mcg QW for the first 4 weeks, followed by Q3W dosing commencing on week 5 for the remainder of the treatment period.

    Placebo QW for the first 4 weeks, followed by Q3W dosing commencing on week 5 for the remainder of the treatment period.

    Outcomes

    Primary Outcome Measures

    Change in hemoglobin concentration from baseline to the end of the chemotherapy treatment period
    Survival time

    Secondary Outcome Measures

    Change in FACT-fatigue subscale scores from baseline to the end of study treatment
    Incidence of Adverse Events (including serious and treatment related)
    Changes in laboratory values, changes in vital signs and incidence of concomitant medications

    Full Information

    First Posted
    July 7, 2005
    Last Updated
    August 7, 2008
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00119613
    Brief Title
    A Study of Subjects With Previously Untreated Extensive-Stage Small-Cell Lung Cancer (SCLC) Treated With Platinum Plus Etoposide Chemotherapy With or Without Darbepoetin Alfa
    Official Title
    A Randomized, Double Blind, Placebo-Controlled Study of Subjects With Previously Untreated Extensive-Stage Small-Cell Lung Cancer (SCLC) Treated With Platinum Plus Etoposide Chemotherapy With or Without Darbepoetin Alfa
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2002 (undefined)
    Primary Completion Date
    January 2007 (Actual)
    Study Completion Date
    April 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate whether increasing or maintaining hemoglobin concentrations with darbepoetin alfa, when administered with platinum-containing chemotherapy in subjects with previously untreated extensive-stage small cell lung cancer (SCLC), increases survival.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Small Cell Lung Cancer
    Keywords
    Oncology, Clinical Trial, Hemoglobin, Darbepoetin alfa, Survival, Carboplatin, Cisplatin, Etoposide, Extensive Stage Small Cell Lung Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1 - darbepoetin alfa
    Arm Type
    Experimental
    Arm Description
    Darbepoetin alfa 300 mcg QW for the first 4 weeks, followed by Q3W dosing commencing on week 5 for the remainder of the treatment period.
    Arm Title
    Group 2 - Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo QW for the first 4 weeks, followed by Q3W dosing commencing on week 5 for the remainder of the treatment period.
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    placebo
    Intervention Type
    Drug
    Intervention Name(s)
    darbepoetin alfa
    Intervention Description
    darbepoetin alfa
    Primary Outcome Measure Information:
    Title
    Change in hemoglobin concentration from baseline to the end of the chemotherapy treatment period
    Time Frame
    from baseline to the end of the chemotherapy treatment period
    Title
    Survival time
    Secondary Outcome Measure Information:
    Title
    Change in FACT-fatigue subscale scores from baseline to the end of study treatment
    Time Frame
    from baseline to the end of study treatment
    Title
    Incidence of Adverse Events (including serious and treatment related)
    Time Frame
    Throughout study
    Title
    Changes in laboratory values, changes in vital signs and incidence of concomitant medications
    Time Frame
    Throughout study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Pathologically proven SCLC, extensive-stage Planned to receive chemotherapy of carboplatin or cisplatin plus etoposide every 3 weeks for 6 cycles Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Life expectancy greater than or equal to 3 months Hemoglobin concentration greater than or equal to 9.0 g/dL and less than or equal to 13g/dL Adequate renal, liver and hematopoietic function Subjects must sign and date a written Institutional Review Board /Independent Ethics Committee-approved Informed Consent Form Exclusion Criteria: Known primary hematologic disorder which could cause anemia Brain metastases that are either symptomatic or treated with medications Unstable or uncontrolled disease/condition, related to or affecting cardiac function Other known primary malignancy within the past 5 years with the exception of curatively treated basal cell carcinoma, squamous cell carcinoma in situ cervical carcinoma or surgically cured malignancies Iron deficiency Known positive test for human immunodeficiency virus infection Received greater than 2 units of packed red blood cells within 4 weeks of randomization or any RBC transfusions within 2 weeks before randomization Received rHuEPO or darbepoetin alfa therapy within 4 weeks of randomization Previous chemotherapy for SCLC Previous radiotherapy except as symptom palliation for bone or brain lesions and at least 24 hours since prior radiotherapy for symptom palliation providing extent of radiotherapy makes marked bone marrow suppression unlikely Less than 30 days since receipt of any drug or device that is not approved for any indication Pregnant or breast-feeding Not using adequate contraceptive precautions Previously randomized into this study Known hypersensitivity to recombinant mammalian-derived product or any other ingredients contained in the study drug Any medical, mental, or other conditions that makes the subject unsuitable for participation
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18467726
    Citation
    Pirker R, Ramlau RA, Schuette W, Zatloukal P, Ferreira I, Lillie T, Vansteenkiste JF. Safety and efficacy of darbepoetin alpha in previously untreated extensive-stage small-cell lung cancer treated with platinum plus etoposide. J Clin Oncol. 2008 May 10;26(14):2342-9. doi: 10.1200/JCO.2007.15.0748.
    Results Reference
    result
    Links:
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/20010145_Clinical_Trial_Posting.pdf
    Description
    To access clinical trial results information click on this link
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
    Description
    Notice regarding posted summaries of trial results
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/20010145_Clinical_Trial_Posting_Apr_20.pdf
    Description
    To access clinical trial results information click on this link

    Learn more about this trial

    A Study of Subjects With Previously Untreated Extensive-Stage Small-Cell Lung Cancer (SCLC) Treated With Platinum Plus Etoposide Chemotherapy With or Without Darbepoetin Alfa

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