Clinical Trials /

Stereotactic Radiosurgery or Other Local Ablation Then Erlotinib in Epidermal Growth Factor Receptor (EGFR)

NCT01573702

Description:

- Progression free survival after locally ablative therapy and erlotinib in EGFR patients progressed after EGFR-TKI therapy

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Stereotactic Radiosurgery or Other Local Ablation Then Erlotinib in Epidermal Growth Factor Receptor (EGFR)
  • Official Title: Phase II Study of Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib for Patients With Epidermal Growth Factor Receptor(EGFR) Mutation Who Have Previously Progressed on an Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor (EGFR-TKI)

Clinical Trial IDs

  • ORG STUDY ID: LCCC 1123
  • NCT ID: NCT01573702

Conditions

  • Non Small Cell Lung Cancer

Interventions

DrugSynonymsArms
ErlotinibTarcevaSingle Arm Study

Purpose

- Progression free survival after locally ablative therapy and erlotinib in EGFR patients progressed after EGFR-TKI therapy

Detailed Description

      Primary Objectives

      - To estimate progression free survival (PFS) after locally ablative therapy and erlotinib in
      EGFR-mutant NSCLC patients who progressed on prior EGFR-TKI therapy

      Secondary Objectives

        -  To evaluate local control of sites previously progressive on erlotinib following
           stereotactic radiosurgery (SRS) followed by erlotinib

        -  To estimate overall survival (OS) after locally ablative therapy and erlotinib in
           EGFR-mutant NSCLC patients who progressed on prior EGFR-TKI therapy

        -  To characterize the toxicity of SRS

        -  To characterize the toxicity of erlotinib when preceded by SRS

      Exploratory Objectives

        -  To explore if VeriStrat results at initial progression are associated with longer PFS or
           OS after study treatment

        -  To explore if VeriStrat results following completion of SRS are associated with longer
           PFS or OS after re-initiation of erlotinib

        -  To explore whether "poor" VeriStrat signatures ever turn to "good" signatures with the
           study therapy, and to explore PFS and OS of patients whose signature changes
    

Trial Arms

NameTypeDescriptionInterventions
Single Arm StudyOtherStereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib
  • Erlotinib

Eligibility Criteria

        Inclusion Criteria:

          -  Written informed consent

          -  18 years of age or older

          -  Histologically or cytologically confirmed stge IV EGFR-mutant NSCLC

          -  History of previous response to EGFR-TKI defined by a RECIST 1.1 criteria

          -  Progressive disease following EGFR-TKI therapy

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Adequate organ and marrow function

          -  Negative urine or serum pregnancy test for female patients

          -  Patients who can have children must agree to adequate contraception

        Exclusion Criteria:

          -  Unresolved chronic toxicities greater than 2, measured by CTCAE v4

          -  Treatment with any FDA approved or experimental cancer treatment following progression
             on EGFR-TKI

          -  Any history of previous greater than grade 3 toxicity attributable to erlotinib

          -  Pregnant or lactating female

          -  Any previous radiation to sites of planned Stereostatic Radiosurgery

          -  History of another malignancy

          -  Concomitant anticancer therapy, immunotherapy, or radiation therapy (within 4 weeks)

          -  Evidence of severe or uncontrolled systemic diseases

          -  Known hypersensitivity reaction or idiosyncrasy to erlotinib

          -  Psychological, familial, sociological, or geographical conditions

          -  Any other condition in investigator's opinion jeopardize compliance with protocol
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression free survival in EGFR-mutant after erlotinib
Time Frame:Initiation of Stereostatic Radiotherapy every 6 to 12 weeks until progression
Safety Issue:
Description:Progression free survival (PFS) after locally ablative therapy and erlotinib in EGFR-mutant NSCLC patients who progressed on prior EGFR-TKI therapy

Secondary Outcome Measures

Measure:Sites progressing on erlotinib following Stereotactic Radiosurgery
Time Frame:Initiation of Stereostatic Radiotherapy every 6 to 12 weeks until progression
Safety Issue:
Description:To evaluate local control of sites previously progressive on erlotinib following SRS followed by erlotinib
Measure:Progression after Stereotactic Radiosurgery
Time Frame:Initiation of Stereostatic Radiosurgery every 6 to 12 weeks until progression
Safety Issue:
Description:To estimate OS after locally ablative therapy and erlotinib in EGFR-mutant NSCLC patients who progressed on prior EGFR-TKI therapy
Measure:Toxicity of SRS
Time Frame:Continuous from study entry through 6 months
Safety Issue:
Description:Toxicity of SRS will be measured by NCI CTCAE version 4 following completion of SRS, but prior to erlotinib re-initiation.
Measure:Toxicity of Erlotinib
Time Frame:Continuous from study entry through 6 months
Safety Issue:
Description:Toxicity of erlotinib will be graded using NCI CTCAE version 4 completion of SRS, but prior to erlotinib re-initiation.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:UNC Lineberger Comprehensive Cancer Center

Trial Keywords

  • Non small cell lung cancer
  • EGFR mutant
  • Phase II
  • erlotinib
  • tarceva
  • cyberknife
  • Lineberger

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