Gemcitabine, Cisplatin, and Gefitinib in Treating Patients Who Are Undergoing Surgery for Stage III Non-Small Cell Lung Cancer
Lung Cancer

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIA non-small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed primary non-small cell lung cancer (NSCLC) Clinical stage IIIA by chest CT scan Unresectable N2 disease by mediastinoscopy, mediastinotomy, thoracotomy, or video-assisted thoracic surgery Measurable disease At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan Planning to undergo lobectomy or pneumonectomy after induction therapy No N3 or metastatic disease by physical exam, thoracic CT scan, bone scan, and CT scan or ultrasound of the liver and adrenal glands No pleural or pericardial effusion No superior vena cava syndrome No diffuse interstitial pulmonary fibrosis No signs or symptoms of CNS involvement PATIENT CHARACTERISTICS: Age Over 18 Performance status WHO 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count > 1,500/mm^3 Platelet count > 100,000/mm^3 Hepatic AST and ALT ≤ 1.5 times upper limit of normal (ULN) Bilirubin normal Alkaline phosphatase ≤ 2.5 times ULN Renal Creatinine ≤ 1.25 times ULN Creatinine clearance ≥ 60 mL/min Cardiovascular No medically uncontrolled congestive heart failure or angina pectoris No uncontrolled hypertension or arrhythmia No myocardial infarction within the past year Other Not pregnant or nursing Fertile patients must use effective contraception Physically and mentally fit to receive gemcitabine- and cisplatin-containing chemotherapy Physiologically fit to undergo surgery No uncontrolled, active infection requiring IV antibiotics No history of hypersensitivity to gefitinib or any of its excipients No motor or sensory neurotoxicity ≥ grade 2 No other primary malignancy within the past 5 years except carcinoma in situ of the cervix or adequately treated basal cell skin cancer No prior melanoma, breast cancer, or renal cell cancer No psychological, familial, sociological, or geographical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunotherapy Chemotherapy No prior chemotherapy for NSCLC No other concurrent chemotherapy Endocrine therapy No concurrent antiestrogen therapy Concurrent replacement steroids and antiemetic steroids allowed Radiotherapy No prior radiotherapy for NSCLC Surgery See Disease Characteristics No prior surgery for NSCLC Other More than 1 month since prior and no concurrent investigational agents No other prior therapy for NSCLC No concurrent CYP3A4 inducers, including any of the following: Phenytoin Carbamazepine Rifampin Barbiturates (e.g., phenobarbital) Hypericum perforatum (St. John's wort) No concurrent systemic retinoids No other concurrent antitumor therapy
Sites / Locations
- Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital