Erlotinib, Paclitaxel, and Carboplatin in Treating Patients With Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Lung Cancer

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Pathologically confirmed non-small cell lung cancer Stage IIIB or IV or recurrent disease Measurable or evaluable indicator lesions Must have smoked ≥ 100 cigarettes in his/her lifetime PATIENT CHARACTERISTICS: Karnofsky performance status 70-100% WBC ≥ 4,000/mm^3 Platelet count ≥ 100,000/mm^3 Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min Bilirubin ≤ 1.0 mg/dL AST ≤ 2.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2.5 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for ≥ 1 week after completion of study treatment No gastrointestinal tract disease or inability to take oral medication No prior malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No other active medical problems, including severe infection, unstable angina, or myocardial infarction within the past 6 months No poorly controlled hypertension or severe malnutrition No New York Heart Association class III or IV congestive heart failure or serious cardiac arrhythmia requiring medication except chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) PRIOR CONCURRENT THERAPY: At least 3 weeks since prior radiotherapy to major bone marrow-containing sites No prior chemotherapy for advanced non-small cell lung cancer No prior agents directed at the epidermal growth factor receptor (EGFR)/HER axis (e.g., gefitinib, cetuximab, or trastuzumab [Herceptin®]) No prior surgical procedure resulting in abnormal absorption of oral medications No concurrent surgical resection, palliative radiotherapy, or hormonal therapy No other concurrent anticancer therapy
Sites / Locations
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Memorial Sloan-Kettering Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
150 PRE
1,500 PRE
1,500 POST
Erlotinib 150mg on days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200 mg/m2
Erlotinib 1500mg on Days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200mg/m2
Carboplatin AUC6, Paclitaxel 200 mg/m2 followed by Erlotinib 1500mg days 2 and 3.