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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
Collaborator:
Astellas Pharma Global Development, Inc.
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01573702
First received: April 5, 2012
Last updated: October 6, 2014
Last verified: October 2014
  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: Stereostatic Radiosurgery
Drug: Erlotinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Evaluate local control of sites previously on erlotinib following SRS followed by erlotinib


Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Stereostatic 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 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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573702

Contacts
Contact: Jared Weiss, MD 919-843-7718 jared_weiss@med.unc.edu
Contact: Donna Rowe, RN 919-966-7359 donna_rowe@med.unc.edu

Locations
United States, California
University of California at San Francisco Recruiting
San Francisco, California, United States, 94115
Principal Investigator: Matthew Gubens, MD, MS         
United States, Colorado
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: Eamon Berge, MD         
United States, Connecticut
Yale University Medical Center Recruiting
New Haven, Connecticut, United States, 06520
Principal Investigator: Roy Decker, MD         
United States, North Carolina
Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Principal Investigator: Paul Walker, MD         
United States, Ohio
STO Taussig Cancer Center; Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: Nathan Pennell, MD, PhD         
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Principal Investigator: Hossein Borghaei, MS, DO         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Principal Investigator: Liza Villaruz, MD         
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Principal Investigator: Howard West, MD         
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

No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01573702     History of Changes
Other Study ID Numbers: LCCC 1123
Study First Received: April 5, 2012
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Erlotinib
Mitogens
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014