Neoadjuvant IRESSA As Single Agent PreopTherapy for NSCLC With Molecular Correlates
Lung Cancer

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IA non-small cell lung cancer, stage IB non-small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed resectable non-small cell lung cancer (NSCLC), meeting 1 of the following clinical staging criteria: Stage IA or IB (T1-2, N0) Stage II (T1-2, N1 with negative mediastinoscopy or T3, N0) Stage IIIA (T3, N1 with negative mediastinoscopy) Level 10 hilar nodes may be positive provided mediastinoscopy is negative The following are not allowed (as evidenced by clinical staging criteria [CT scan, positron-emission tomography (PET) scan, or mediastinoscopy): Positive N2 lymph nodes (ipsilateral/subcarinal mediastinal lymph nodes) Positive N3 lymph nodes (contralateral mediastinal/hilar and supraclavicular/scalene lymph nodes) T4 primary tumor (malignant pleural effusion or mediastinal invasion) Symptomatic tumors (T3, N0-1) involving the superior sulcus (i.e., Pancoast tumors) Measurable disease by contrast-enhanced CT scan No metastatic disease (except peribronchial or hilar lymph node involvement [N1]) by fludeoxyglucose F 18 PET scan No malignant pleural effusion by preoperative evaluation Pleural effusions visible only on CT scan that are not large enough for safe thoracentesis are allowed No exudative effusions (even if cytologically negative), as evidenced by any of the following: Ratio of pleural fluid protein to serum protein > 0.5 Ratio of pleural fluid lactic dehydrogenase (LDH) to serum LDH ≥ 0.6 Pleural fluid LDH > 200 IU/L No superior vena cava syndrome No spinal cord compression PATIENT CHARACTERISTICS: Age 18 and over Performance status Eastern Cooperative Oncology Group (ECOG) 0-1 Life expectancy Not specified Hematopoietic WBC ≥ 4,000/mm^3 Absolute granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST or ALT ≤ 2 times ULN Alkaline phosphatase ≤ 2 times ULN Renal Creatinine < 1.5 times ULN Cardiovascular No uncontrolled ventricular arrhythmia No myocardial infarction within the past 3 months Pulmonary Pre-resection FEV_1 > 2.0 L OR Predicted post-resection FEV_1 > 1.0 L No clinically active interstitial lung disease Chronic stable asymptomatic radiographic changes allowed No post-obstructive pneumonia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Willing to provide tumor biopsy pre- and post-gefitinib administration AND undergo PET scan No known severe hypersensitivity to study drug or any of its excipients No uncontrolled major seizure disorder No unstable or uncontrolled diabetes mellitus No serious infection requiring IV antibiotics No grade 3 neuropathy No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No other unstable or serious medical condition that would preclude study treatment or surgery No psychiatric disorder that would preclude giving informed consent No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow up No other significant clinical disorder or laboratory finding that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior or concurrent systemic chemotherapy for NSCLC Endocrine therapy Not specified Radiotherapy No prior or concurrent radiotherapy for NSCLC Surgery Recovered from prior oncologic or other major surgery At least 5 years since prior resection of lung disease No prior surgery for NSCLC No concurrent ophthalmic surgery Other More than 30 days since prior non-approved or investigational drugs No other concurrent therapy for NSCLC No other concurrent investigational therapy No concurrent use of any of the following medications: Phenytoin Carbamazepine Barbiturates (e.g., phenobarbital) Rifampin Hypericum perforatum (St. John's wort)
Sites / Locations
- H. Lee Moffitt Cancer Center and Research Institute
Arms of the Study
Arm 1
Experimental
Neoadjuvant ZD1839 Preoperative Therapy
The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food. At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.