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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01573702
First Posted: April 9, 2012
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Astellas Pharma Global Development, Inc.
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
  Purpose
- Progression free survival after locally ablative therapy and erlotinib in EGFR patients progressed after EGFR-TKI therapy

Condition Intervention Phase
Non Small Cell Lung Cancer Procedure: Stereotactic Radiosurgery Drug: Erlotinib Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
For all patients, all sites of progressive disease will be treated with local ablation (primarily stereotactic radiosurgery) followed by the EGFR-TKI erlotinib until disease progression.
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Progression free survival in EGFR-mutant after erlotinib [ Time Frame: Initiation of Stereostatic Radiotherapy every 6 to 12 weeks until progression ]
    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:
  • Sites progressing on erlotinib following Stereotactic Radiosurgery [ Time Frame: Initiation of Stereostatic Radiotherapy every 6 to 12 weeks until progression ]
    To evaluate local control of sites previously progressive on erlotinib following SRS followed by erlotinib

  • Progression after Stereotactic Radiosurgery [ Time Frame: Initiation of Stereostatic Radiosurgery every 6 to 12 weeks until progression ]
    To estimate OS after locally ablative therapy and erlotinib in EGFR-mutant NSCLC patients who progressed on prior EGFR-TKI therapy

  • Toxicity of SRS [ Time Frame: Continuous from study entry through 6 months ]
    Toxicity of SRS will be measured by NCI CTCAE version 4 following completion of SRS, but prior to erlotinib re-initiation.

  • Toxicity of Erlotinib [ Time Frame: Continuous from study entry through 6 months ]
    Toxicity of erlotinib will be graded using NCI CTCAE version 4 completion of SRS, but prior to erlotinib re-initiation.


Estimated Enrollment: 32
Study Start Date: January 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Arm Study
Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib
Procedure: Stereotactic Radiosurgery
21 Gy daily for 5 days
Other Name: Cyberknife
Drug: Erlotinib
150mg once daily
Other Name: Tarceva

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01573702


Locations
United States, California
University of California at San Francisco
San Francisco, California, United States, 94115
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, North Carolina
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
East Carolina University
Greenville, North Carolina, United States, 27834
United States, Ohio
STO Taussig Cancer Center; Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Astellas Pharma Global Development, Inc.
Investigators
Principal Investigator: Jared Weiss, MD UNC at Chapel Hill
  More Information

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01573702     History of Changes
Other Study ID Numbers: LCCC 1123
First Submitted: April 5, 2012
First Posted: April 9, 2012
Last Update Posted: September 25, 2017
Last Verified: September 2017

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Non small cell lung cancer
EGFR mutant
Phase II
erlotinib
tarceva
cyberknife
Lineberger

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib Hydrochloride
Mitogens
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Mitosis Modulators