Neoadjuvant Chemoradiotherapy With or Without Gefitinib in Treating Patients With Stage IIIA or Stage IIIB 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, stage IIIB non-small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer Stage IIIA (T1-3, N2) Positive (pathological) ipsilateral mediastinal node Selective stage IIIB meeting all of the following criteria: No pleural/pericardial effusion or superior vena cava syndrome T4 due to invasion of carina, trachea, or mediastinal structures Mediastinal N3 nodes (without supraclavicular or cervical adenopathy) Proof of N2 or N3 status requires surgical staging of the mediastinum (mediastinoscopy, mediastinotomy, or exploration) Expression of epidermal growth factor receptor (at least 1+) by immunohistochemistry Measurable disease by contrast CT scan allowed No bronchoalveolar cell carcinoma No prior diagnosis of lung cancer PATIENT CHARACTERISTICS: Age 19 and over Performance status ECOG 0-1 (0-2 if albumin is at least 0.85 times lower limit of normal and weight loss within 3 months before diagnosis is no greater than 10%) Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 150,000/mm^3 Hemoglobin at least 10 g/dL Hepatic Bilirubin normal AST and ALT no greater than 2.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN Alkaline phosphatase between 1.5-2 times ULN requires a negative bone scan for metastatic bone disease Renal Creatinine no greater than 1.4 mg/dL OR Creatinine clearance at least 60 mL/min Cardiac No myocardial infarction within the past 3 months No active angina No unstable heart rhythms No congestive heart failure Pulmonary Post-resection predicted FEV_1% greater than 35% Predicted FEV_1% is defined as FEV_1% times percent perfusion to uninvolved lung from quantitative lung V/Q scan report Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 6 weeks after study treatment No other uncontrolled medical illness No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix No grade 2 or greater peripheral neuropathy No concurrent ocular inflammation or infection No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 No known severe hypersensitivity reaction to gefitinib or any of its excipients No prior severe allergic reaction to platinum-containing compounds or mannitol PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent growth factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) during chemotherapy Chemotherapy No prior chemotherapy for lung cancer Endocrine therapy Not specified Radiotherapy No prior radiotherapy for lung cancer Surgery Recovered from prior major surgery No concurrent ophthalmic surgery Other More than 30 days since prior unapproved or investigational drugs No concurrent use of the following drugs: Phenytoin Carbamazepine Barbiturates Rifampin Phenobarbital Hypericum perforatum (St. John's Wort) Warfarin No concurrent retinoids
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center