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Erlotinib Re-Challenge for Recurrent EGFR-mutant Lung Cancer in Patients Who Previously Received Adjuvant Erlotinib or Gefitinib

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ClinicalTrials.gov Identifier: NCT01189435
Recruitment Status : Terminated (Lack of accrual)
First Posted : August 26, 2010
Results First Posted : April 21, 2015
Last Update Posted : November 18, 2015
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE August 25, 2010
First Posted Date  ICMJE August 26, 2010
Results First Submitted Date  ICMJE April 7, 2015
Results First Posted Date  ICMJE April 21, 2015
Last Update Posted Date November 18, 2015
Study Start Date  ICMJE August 2010
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2011)
To Examine the Objective Response Rate (ORR) of Single-agent Erlotinib [ Time Frame: 2 years ]
in recurrent EGFR-mutant lung cancer, given to patients who previously received adjuvant erlotinib or gefitinib
Original Primary Outcome Measures  ICMJE
 (submitted: August 25, 2010)
To Examine the Objective Response Rate (ORR) of Single-agent Erlotinib [ Time Frame: 2 years ]
in recurrent EGFR-mutant lung cancer, given to patients who previously received adjuvant erlotinib
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2010)
  • To examine the progression free survival (PFS) [ Time Frame: 2 years ]
    of patients receiving single-agent erlotinib for recurrent EGFR-mutant lung cancer following previous adjuvant erlotinib
  • To examine overall survival (OS) [ Time Frame: 2 years ]
    of patients receiving single-agent erlotinib for recurrent EGFR-mutant lung cancer following previous adjuvant erlotinib
  • To estimate the prevalence of EGFR T790M mutation [ Time Frame: 2 years ]
    in patients who have recurrent lung cancer after stopping adjuvant erlotinib
  • To examine the correlation of T790M mutation [ Time Frame: 2 years ]
    with ORR and PFS in patients receiving erlotinib
  • To estimate the accuracy of circulating tumor cells (CTCs) [ Time Frame: Within 2 weeks of starting erlotinib ]
    at non-invasively detecting EGFR and T790M mutations in patients with recurrent lung cancer.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Erlotinib Re-Challenge for Recurrent EGFR-mutant Lung Cancer in Patients Who Previously Received Adjuvant Erlotinib or Gefitinib
Official Title  ICMJE A Phase 2 Trial of Erlotinib Re-Challenge for Recurrent EGFR-mutant Lung Cancer in Patients Who Previously Received Adjuvant Erlotinib or Gefitinib
Brief Summary The purpose of this study is to measure the ability of erlotinib to effectively treat recurrent lung cancer which carries an EGFR mutation lung cancer after prior treatment with erlotinib or gefitinib received in the post-surgical or post-radiation setting.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE Drug: erlotinib
After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST.
Study Arms  ICMJE Experimental: erlotinib
This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.
Intervention: Drug: erlotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 8, 2011)
2
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2010)
21
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • A history of stage I-IIIB NSCLC
  • Previously underdone definitive surgery or radiation
  • Received prior adjuvant treatment or neoadjuvant with erlotinib or gefitinib for a total of at least 3 months at any time
  • Stopped adjuvant erlotinib or neoadjuvant at least 2 months prior to date of first imaging demonstrating recurrence
  • Pathologic evidence of recurrent lung cancer, confirmed at MSKCC EGFR sensitizing mutation (point mutation in exons 18 or 21, or deletion in exon 19) must be documented in the primary or recurrent tumor
  • Tissue from their recurrent tumor must be submitted for EGFR mutation testing, and to evaluate for the presence of the T790M mutation (results do not need to have been reported to be eligible)
  • Measurable disease by RECIST; if received prior irradiation, then must have a target lesion outside the irradiated field
  • Signed informed consent
  • Age > or = to 21 years old
  • Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped

Exclusion Criteria:

  • Prior progressive disease while receiving erlotinib or gefitinib therapy
  • Patients with known pre-existing interstitial lung disease
  • Total bilirubin greater than 1.8 mg/dl, excepting patients known to have Gilbert's syndrome
  • AST or ALT greater than five times the upper limit of normal
  • Pregnant or lactating women
  • Medically unfit for erlotinib therapy as determined by treating oncologist
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01189435
Other Study ID Numbers  ICMJE 10-097
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher Azzoli, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP