Clinical trial NCT01573702: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: Non small cell lung cancer
EGFR mutant
Phase II
erlotinib
tarceva
cyberknife
Lineberger
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Global Development, Inc.
First posted: 2012-04-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

Brief summary: - 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

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

Primary outcomes:
measure: Percentage of Participants With Progression Free Survival
timeFrame: 3 months after Initiation of Stereostatic Radiotherapy
Secondary outcomes:
measure: Percentage of Participants With Local Control of Sites on Erlotinib Following Stereotactic Radiosurgery (SRS)
timeFrame: Initiation of Stereotactic Radiotherapy every 6 to 12 weeks until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
measure: Median Overall Survival
timeFrame: up to 5 years after end of treatment
measure: Toxicity Rate From Stereotactic Radiosurgery (SRS)
timeFrame: From initiation to the end of SRS, up to 15 days
measure: Toxicity Rate Attributed to Erlotinib
timeFrame: from end of SRS to end of erlotinib treatment (median duration of 5.7 months)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Cleveland
country: United States
facility: STO Taussig Cancer Center; Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
Study officials:
affiliation: UNC at Chapel Hill
name: Jared Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References: