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ABX-EGF as Second Line 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
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

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

Inclusion Criteria: 18 years of age or older. Diagnosis of NSCLC. Unidimensionally measurable disease. Documented disease progression within 6 months of the subject's last dose of carboplatin and paclitaxel in treatment arm 1, part 2 of Immunex Protocol 054.0004 (Amgen Protocol 20025404). Disease stage IIIB with pericardial or pleural effusion, or stage IV. Life expectancy of at least 12 weeks. ANC greater than or equal to 1.5 x 10^9/L, platelet count greater than or equal to 100 x 10^9/L. 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 paclitaxel and carboplatin per Immunex Protocol 054.0004 (Amgen Protocol 20025404), such as radiation therapy, surgery, or steroids. Paclitaxel or carboplatin within 30 days before the first ABX-EGF infusion. 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

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    ABX-EGF

    Arm Description

    Open-label, single arm panitumamab monotherapy

    Outcomes

    Primary Outcome Measures

    Objective Tumor Response

    Secondary Outcome Measures

    Full Information

    First Posted
    January 18, 2005
    Last Updated
    October 14, 2010
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00101920
    Brief Title
    ABX-EGF as Second Line Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)
    Official Title
    A Clinical Trial of the Safety and Efficacy of ABX-EGF as Second Line Treatment for Advanced Non-Small Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2003 (undefined)
    Primary Completion Date
    December 2004 (Actual)
    Study Completion Date
    December 2004 (Actual)

    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 the treatment of advanced NSCLC following failure of paclitaxel and carboplatin therapy on treatment arm 1 of Immunex Protocol 054.0004 (Amgen Protocol 20025404), Part 2.

    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ABX-EGF
    Arm Type
    Experimental
    Arm Description
    Open-label, single arm panitumamab monotherapy
    Intervention Type
    Drug
    Intervention Name(s)
    ABX-EGF
    Intervention Description
    2.5 mg/kg by an infusion pump over one hour
    Primary Outcome Measure Information:
    Title
    Objective Tumor Response
    Time Frame
    End of initial 6 week treatment period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years of age or older. Diagnosis of NSCLC. Unidimensionally measurable disease. Documented disease progression within 6 months of the subject's last dose of carboplatin and paclitaxel in treatment arm 1, part 2 of Immunex Protocol 054.0004 (Amgen Protocol 20025404). Disease stage IIIB with pericardial or pleural effusion, or stage IV. Life expectancy of at least 12 weeks. ANC greater than or equal to 1.5 x 10^9/L, platelet count greater than or equal to 100 x 10^9/L. 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 paclitaxel and carboplatin per Immunex Protocol 054.0004 (Amgen Protocol 20025404), such as radiation therapy, surgery, or steroids. Paclitaxel or carboplatin within 30 days before the first ABX-EGF infusion. 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 as Second Line Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)

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