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

Lung Cancer Clinical Trial

Official title:

A Phase 2 Trial of Erlotinib Re-Challenge for Recurrent EGFR-mutant Lung Cancer in Patients Who Previously Received Adjuvant Erlotinib or Gefitinib

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01189435
• Other study ID #: 10-097
• Status: Terminated
• Phase: Phase 2
• First received: August 25, 2010
• Last updated: October 17, 2015
• Start date: August 2010
• Est. completion date: January 2012

Study information

• Verified date: October 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Examine the Objective Response Rate (ORR) of Single-agent Erlotinib	in recurrent EGFR-mutant lung cancer, given to patients who previously received adjuvant erlotinib or gefitinib	2 years	No

External Links

•   Memorial Sloan Kettering Cancer Center