Erlotinib Hydrochloride Before Surgery in Treating Patients With Stage III Non-Small Cell Lung Cancer
Condition: Stage IIIA Non-Small Cell Lung Cancer; Stage IIIB Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Erlotinib Hydrochloride; Therapeutic Conventional Surgery; Laboratory Biomarker Analysis
Intervention description: Given PO; Undergo thoracotomy; Correlative studies
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well erlotinib hydrochloride works before surgery in treating
      patients with stage III non-small cell lung cancer. Erlotinib hydrochloride may stop the
      growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving
      erlotinib hydrochloride before surgery may make the tumor smaller and reduce the amount of
      normal tissue that needs to be removed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically proven (either histologic or cytologic) diagnosis of stage IIIA or IIIB
             non-small cell lung cancer; (according to American Joint Committee on Cancer [AJCC]
             staging, 7th edition) within 4 weeks of registration; the patient should have
             histologically or cytologically confirmed N2 disease

          -  Activating mutation in EGFR

          -  No prior chemotherapy or radiation for lung cancer

          -  Patients may be potentially resectable or unresectable

          -  Stage III A or B disease, including no distant metastases- based on following
             diagnostic workup:

               -  History/physical examination prior to registration

               -  Computed tomography (CT) scan of the chest or positron emission tomography (PET)
                  scan within 28 days of study entry

               -  CT scan of abdomen or magnetic resonance imaging (MRI) of abdomen or PET scan
                  within 28 days of study entry

               -  An MRI of the brain or head CT scan with contrast within 28 days of study entry

               -  Total body PET scan within 28 days of study entry

               -  Mediastinoscopies are highly recommended

          -  Patients must have measurable or evaluable disease

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Absolute neutrophil count (ANC) >= 1,500 cells/ul

          -  Platelets >= 100,000 cells/ul

          -  Hemoglobin >= 9.0 g/dl (note: the use of transfusion or other intervention to achieve
             hemoglobin [Hgb] >= g/dl is acceptable)

          -  Serum creatinine =< 1.5 x upper limit of normal (ULN)

          -  Total bilirubin < 2.0 times the institutional upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x the ULN

          -  Women of childbearing potential must have:

               -  A negative serum or urine pregnancy test (sensitivity =< 25 IU human chorionic
                  gonadotropin [HCG]/L) within 72 hours prior to the start of study drug
                  administration

               -  Persons of reproductive potential must agree to use and utilize an adequate
                  method of contraception throughout treatment and for at least 4 weeks after study
                  drug is stopped prior to study enrollment, women of childbearing potential must
                  be advised of the importance of avoiding pregnancy during trial participation and
                  the potential risk factors for an unintentional pregnancy

          -  Ability to take oral medication

          -  Patient must sign study specific informed consent prior to study entry

        Exclusion Criteria:

          -  Pleural or pericardial effusion

               -  Pleural effusions allowed if one of the following conditions are met: 1) negative
                  cytology after adequate sampling by thoracentesis 2) effusion seen on CT scan but
                  not on chest x-ray and deemed too small to tap under CT or ultrasound guidance

          -  Severe, active co-morbidity, defined as follows:

               -  Cardiac symptoms; any of the following should be considered for exclusion:

                    -  Uncontrolled angina, congestive heart failure or myocardial infarction (MI)
                       within (6 months)

                    -  Diagnosed congenital long QT syndrome

                    -  Any history of clinically significant ventricular arrhythmias (such as
                       ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)

                    -  Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (> 450
                       msec)

          -  History of significant bleeding disorder unrelated to cancer, including:

               -  Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)

               -  Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor
                  VIII antibodies)

               -  Ongoing or recent (=< 3 months) significant gastrointestinal bleeding

          -  Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
             treatment of either a psychiatric or physical (e.g., infectious) illness

          -  Men and women who:

               -  Are unwilling or unable to use an acceptable method to avoid pregnancy for the
                  entire study period and for at least 4 weeks after cessation of study drug, or
                  women who:

                    -  Have a positive pregnancy test at baseline, or

                    -  Are pregnant or breastfeeding