Status:
TERMINATED
Erlotinib Hydrochloride Before Surgery in Treating Patients With Stage III Non-Small Cell Lung Cancer
Lead Sponsor:
Albert Einstein College of Medicine
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Stage IIIA Non-Small Cell Lung Cancer
Stage IIIB Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 c...
Detailed Description
PRIMARY OBJECTIVES: I. To estimate the rate of mediastinal nodal clearance and complete pathological response after neoadjuvant erlotinib (erlotinib hydrochloride) in patients with epidermal growth f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2017
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01857271
Start Date
November 1 2013
End Date
August 31 2017
Last Update
July 8 2020
Active Locations (3)
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1
Columbia University Medical Center
New York, New York, United States, 10032
2
Weill Cornell Medical College
New York, New York, United States, 10065
3
Albert Einstein College of Medicine
The Bronx, New York, United States, 10461