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Second Line Erlotinib (Tarceva) Plus Digoxin in Non-Small Cell Lung Cancer

Primary Purpose

Carcinoma, Non-Small Cell Lung

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Erlotinib plus Digoxin
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small Cell Lung focused on measuring non-small cell lung cancer, Erlotinib, Digoxin

Eligibility Criteria

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

Inclusion Criteria: diagnosis of non-small cell lung cancer measurable or evaluable disease primary tumor must be documented by histopathic analysis disease recurrences occurring greater than five years after original diagnosis must be biopsy proven treatment with only one prior chemotherapy regimen for advanced disease (one additional prior regimen was allowed for neoadjuvant, adjuvant, or neoadjuvant plus adjuvant therapy) serum creatinine < 2mg/dl, or a calculated creatinine clearance > 40cc/min using the following formula: (140-age) x WT(kg) x 0.85 (if female 0.72) x creatinine (mg/dl). Tests must be done within 28 days prior to registration must have a CT scan (chest & abdomen) within 4 weeks prior to registration Zubrod performance status of 0-3 Exclusion Criteria: women who are pregnant or nursing no other prior malignancy is allowed except for: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years history of ventricular fibrillation, sinus node or AV nodal disease, Wolff Parkinson White Syndrome, evidence of congestive heart failure, chest pain with exertion, hemodynamically significant or life threatening cardiac arrhythmia, or evidence of prior myocardial infarction on EKG. EKG must have been done within 28 days prior to registration. A normal cardiac stress test within 182 days prior to registration is required for all patients over 50 years old or those with abnormal EKG or any history of cardiac disease. hypersensitivity to erlotinib and/or Digoxin abnormal levels of K, Mg, and/or Ca, or conditions which cause such abnormalities (e.g. malnutrition, severe diarrhea, prolonged vomiting, dialysis, GI suction, untreated hypothyroidism, and use of diuretics, amphotericin B, steroids, or antacids)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Erlotinib and Digoxin

    Arm Description

    Erlotinib plus Digoxin

    Outcomes

    Primary Outcome Measures

    Therapeutic Response, Evaluated by Computed Tomography (CT) Scans of Chest & Abdomen.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 23, 2006
    Last Updated
    March 1, 2018
    Sponsor
    University of Louisville
    Collaborators
    James Graham Brown Cancer Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00281021
    Brief Title
    Second Line Erlotinib (Tarceva) Plus Digoxin in Non-Small Cell Lung Cancer
    Official Title
    Phase II Trial of Second Line Erlotinib + Digoxin in Patients With Non-Small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Terminated
    Why Stopped
    Interim analysis revealed that only 1 patient had a partial response.
    Study Start Date
    February 2006 (undefined)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    December 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Louisville
    Collaborators
    James Graham Brown Cancer Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine the potential benefit of adding Digoxin to erlotinib (Tarceva) treatment for patients with non-small cell lung cancer.
    Detailed Description
    Non-small cell lung cancer (NSCLC) accounts for 80% of all lung cancer cases. The majority of NSCLC patients have advanced disease at the time of diagnosis, which usually requires treatment beyond standard first-line chemotherapy. Until recently, patients were limited in the number of options available for second-line treatment of NSCLC. In 2004, erlotinib was approved by the FDA for second and third-line treatment of NSCLC. Erlotinib is a cancer chemotherapy medication that slows the growth and spread of cancer cells in the body. Recent research suggests that a medication called Digoxin can sensitize cancer cells to respond better to chemotherapy. Digoxin is normally used to treat certain heart conditions by helping the heart beat more strongly and regularly and is not approved by the FDA for the treatment of NSCLC. Investigators hope that subject response rates to standard erlotinib therapy will be significantly improved by the addition of Digoxin. The purpose of this study is to determine the tumor response rate and overall survival of patients with non-small cell lung cancer treated with a daily regimen of erlotinib (Tarceva) plus Digoxin.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carcinoma, Non-Small Cell Lung
    Keywords
    non-small cell lung cancer, Erlotinib, Digoxin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    26 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Erlotinib and Digoxin
    Arm Type
    Experimental
    Arm Description
    Erlotinib plus Digoxin
    Intervention Type
    Drug
    Intervention Name(s)
    Erlotinib plus Digoxin
    Other Intervention Name(s)
    Tarceva, Digitalis
    Intervention Description
    Each subject will receive erlotinib and digoxin daily until progression.
    Primary Outcome Measure Information:
    Title
    Therapeutic Response, Evaluated by Computed Tomography (CT) Scans of Chest & Abdomen.
    Time Frame
    Measured every 6 weeks after baseline until disease progression, an average of 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: diagnosis of non-small cell lung cancer measurable or evaluable disease primary tumor must be documented by histopathic analysis disease recurrences occurring greater than five years after original diagnosis must be biopsy proven treatment with only one prior chemotherapy regimen for advanced disease (one additional prior regimen was allowed for neoadjuvant, adjuvant, or neoadjuvant plus adjuvant therapy) serum creatinine < 2mg/dl, or a calculated creatinine clearance > 40cc/min using the following formula: (140-age) x WT(kg) x 0.85 (if female 0.72) x creatinine (mg/dl). Tests must be done within 28 days prior to registration must have a CT scan (chest & abdomen) within 4 weeks prior to registration Zubrod performance status of 0-3 Exclusion Criteria: women who are pregnant or nursing no other prior malignancy is allowed except for: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years history of ventricular fibrillation, sinus node or AV nodal disease, Wolff Parkinson White Syndrome, evidence of congestive heart failure, chest pain with exertion, hemodynamically significant or life threatening cardiac arrhythmia, or evidence of prior myocardial infarction on EKG. EKG must have been done within 28 days prior to registration. A normal cardiac stress test within 182 days prior to registration is required for all patients over 50 years old or those with abnormal EKG or any history of cardiac disease. hypersensitivity to erlotinib and/or Digoxin abnormal levels of K, Mg, and/or Ca, or conditions which cause such abnormalities (e.g. malnutrition, severe diarrhea, prolonged vomiting, dialysis, GI suction, untreated hypothyroidism, and use of diuretics, amphotericin B, steroids, or antacids)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Goetz H Kloecker, MD, MSPH
    Organizational Affiliation
    James Graham Brown Cancer Center/ University of Louisville
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.browncancercenter.org
    Description
    James Graham Brown Cancer Center

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    Second Line Erlotinib (Tarceva) Plus Digoxin in Non-Small Cell Lung Cancer

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