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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

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

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)

Details

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 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 following completion of SRS are associated with longer PFS or OS after re-initiation of erlotinib
  • To explore if VeriStat results following completion of SRS are associated with longer PFS or OS after re-initiation of erlotinib
  • To explore whether "poor" VeriStat signatures every turn to "good" signatures with the study therapy, and to explore PFS and OS of patients whose signature changes
  • To utilize the full NMR peaks from MALDI-TOF to generate hypotheses regarding alternative signatures for evaluation and novel biomarkers

Keywords

Non Small Cell Lung Cancer EGFR mutant Phase II erlotinib tarceva cyberknife Lineberger Erlotinib Hydrochloride Mitogens

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • Swedish Cancer Institute accepting new patients
    Seattle, Washington, 98104, United States
  • University of Colorado Cancer Center accepting new patients
    Aurora, Colorado, 80045, United States
  • STO Taussig Cancer Center; Cleveland Clinic accepting new patients
    Cleveland, Ohio, 44195, United States
  • University of Pittsburgh Medical Center accepting new patients
    Pittsburgh, Pennsylvania, 15232, United States
  • Lineberger Comprehensive Cancer Center accepting new patients
    Chapel Hill, North Carolina, 27599, United States
  • East Carolina University accepting new patients
    Greenville, North Carolina, 27834, United States
  • Fox Chase Cancer Center accepting new patients
    Philadelphia, Pennsylvania, 19111, United States
  • Yale University Medical Center withdrawn
    New Haven, Connecticut, 06520, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
UNC Lineberger Comprehensive Cancer Center
ID
NCT01573702
Phase
Phase 2
Lead Scientist
Matthew Gubens
Study Type
Interventional
Last Updated
September 12, 2016
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