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ABX-EGF in Combination With Paclitaxel and Carboplatin for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)

Primary Purpose

Non-Small Cell Lung Cancer, Neoplasm Metastasis, Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ABX-EGF
paclitaxel
carboplatin
Sponsored by
Amgen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Advanced, Non-Small-Cell, Lung, Cancer, NSCLC, Carcinoma, Advanced Non-Small-Cell Lung Cancer (NSCLC)

Eligibility Criteria

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

For complete inclusion and exclusion criteria, please refer to the investigator. Inclusion Criteria: - 18 years of age or older. - Pathological diagnosis of NSCLC. - Bidimensionally measurable disease. - Tumor tissue available for immunohistochemistry studies. - Tumor over-expressing EGFR as ascertained by immunohistochemistry. - Disease stage IIIB with pericardial or pleural effusion, or stage IV. - Life expectancy of at least 12 weeks. - Adequate hematology function - Adequate renal function - Adequate hepatic function - ECOG score of less than 2. - Brain metastases, if present; must be controlled and asymptomatic. Exclusion Criteria: - Calcium > ULN (treatment for hypercalcemia allowed). - Use of any investigational therapy within 30 days of ABX-EGF infusion. - Any cancer therapy for NSCLC other than radiation therapy, surgery, or steroids. - Radiation therapy within 2 weeks before ABX-EGF infusion. - LVEF less than 45% as measured by MUGA. - Symptomatic ventricular arrhythmia or symptomatic conduction abnormality. - Myocardial infarction within 1 year before first dose of study drug. - History of cancer that has required treatment or been active within past 5 years, other than NSCLC, basal cell carcinoma, or cervical carcinoma in situ. - Women (e.g., of childbearing potential, who are post-menopausal for less than six months, not surgically sterilized or not abstinent) who are not willing to use an oral or implanted contraceptive, double barrier birth control, or an IUD during the course of the study and for 6 months following treatment. - Men not willing to use contraception upon enrollment into this study and for 1 month following treatment. - Women who are breast-feeding or have a positive pregnancy test within 72 hours of first study drug administration. - Known to be HIV positive. - Any patient who's best medical interests would not be met by entry in the study in the opinion of the Investigators.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Time to Disease Progression

    Secondary Outcome Measures

    Best Overall Response Rate
    Response Rate at Week 5
    Survival Time
    Progression Free Survival
    Rate of Progressive Disease at Week 11
    Incidence of AEs
    Lab Abnormalities and other Safety Parameters
    PK of Panitumumab in Combination with Carboplatin and Paclitaxel
    Quality of Life

    Full Information

    First Posted
    April 25, 2002
    Last Updated
    December 20, 2007
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00034346
    Brief Title
    ABX-EGF in Combination With Paclitaxel and Carboplatin for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)
    Official Title
    A Two Part, Multiple Dose Clinical Trial of the Safety and Efficacy of ABX-EGF in Combination With Paclitaxel and Carboplatin in Patients With Advanced Non-Small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

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

    3. Sponsor/Collaborators

    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    Brief Summary
    Rationale: Overexpression of epidermal growth factor receptor (EGFR) has been observed in kidney, prostate, colon, lung, breast, and other cancers, and is often associated with a poor prognosis. TGFa and EGF, the ligands for EGFR, are also overexpressed in some of these tumor types, suggesting a self-propagating stimulus that may be responsible for rapid tumor growth. Blocking this stimulus by blocking activation of EGFR with ABX-EGF, a fully human monoclonal antibody against EGFR, may prevent tumor growth and perhaps shrink tumors. Purpose: This is a Phase 2 clinical trial to evaluate the safety and efficacy of ABX-EGF in combination with paclitaxel and carboplatin in the treatment of advanced NSCLC.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Small Cell Lung Cancer, Neoplasm Metastasis, Lung Cancer
    Keywords
    Advanced, Non-Small-Cell, Lung, Cancer, NSCLC, Carcinoma, Advanced Non-Small-Cell Lung Cancer (NSCLC)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    194 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    ABX-EGF
    Intervention Type
    Drug
    Intervention Name(s)
    paclitaxel
    Intervention Type
    Drug
    Intervention Name(s)
    carboplatin
    Primary Outcome Measure Information:
    Title
    Time to Disease Progression
    Secondary Outcome Measure Information:
    Title
    Best Overall Response Rate
    Title
    Response Rate at Week 5
    Title
    Survival Time
    Title
    Progression Free Survival
    Title
    Rate of Progressive Disease at Week 11
    Title
    Incidence of AEs
    Title
    Lab Abnormalities and other Safety Parameters
    Title
    PK of Panitumumab in Combination with Carboplatin and Paclitaxel
    Title
    Quality of Life

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    For complete inclusion and exclusion criteria, please refer to the investigator. Inclusion Criteria: - 18 years of age or older. - Pathological diagnosis of NSCLC. - Bidimensionally measurable disease. - Tumor tissue available for immunohistochemistry studies. - Tumor over-expressing EGFR as ascertained by immunohistochemistry. - Disease stage IIIB with pericardial or pleural effusion, or stage IV. - Life expectancy of at least 12 weeks. - Adequate hematology function - Adequate renal function - Adequate hepatic function - ECOG score of less than 2. - Brain metastases, if present; must be controlled and asymptomatic. Exclusion Criteria: - Calcium > ULN (treatment for hypercalcemia allowed). - Use of any investigational therapy within 30 days of ABX-EGF infusion. - Any cancer therapy for NSCLC other than radiation therapy, surgery, or steroids. - Radiation therapy within 2 weeks before ABX-EGF infusion. - LVEF less than 45% as measured by MUGA. - Symptomatic ventricular arrhythmia or symptomatic conduction abnormality. - Myocardial infarction within 1 year before first dose of study drug. - History of cancer that has required treatment or been active within past 5 years, other than NSCLC, basal cell carcinoma, or cervical carcinoma in situ. - Women (e.g., of childbearing potential, who are post-menopausal for less than six months, not surgically sterilized or not abstinent) who are not willing to use an oral or implanted contraceptive, double barrier birth control, or an IUD during the course of the study and for 6 months following treatment. - Men not willing to use contraception upon enrollment into this study and for 1 month following treatment. - Women who are breast-feeding or have a positive pregnancy test within 72 hours of first study drug administration. - Known to be HIV positive. - Any patient who's best medical interests would not be met by entry in the study in the opinion of the Investigators.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

    ABX-EGF in Combination With Paclitaxel and Carboplatin for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)

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