Genetic Changes in Patients With Non-Small Cell Lung Cancer Who Are Receiving Vinorelbine and Gemcitabine Before Surgery
Lung Cancer

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed non-small cell carcinoma of the lung May be confirmed at the initial bronchoscopy and mediastinoscopy Stage IB (T2, N0, M0) Stage IIA (T1, N1, M0) Stage IIB (T2-3, N0-1, M0) Stage IIIA (T1-3, N1-2, M0) stage IIIB (2 lesions in 1 lobe [T4]) No N3 lymph nodes (contralateral mediastinal/hilar and supraclavicular/scaline) OR T4 primary tumor (malignant pleural effusion or mediastinal invasion) by clinical staging criteria (seen on CT or PET scan and proven by mediastinoscopy) No metastatic disease (except N1 or N2 disease) or malignant pleural effusion* detected on preoperative evaluation No exudative effusions (even if cytologically negative) Pleural fluid is considered exudative if the following apply: Ratio of pleural fluid protein to serum protein is greater than 0.5 Ratio of pleural fluid lactic dehydrogenase (LDH) to serum LDH is at least 0.6 Pleural fluid LDH is greater than 200 IU/L No multiple areas of fluorodeoxyglucose (FDG) uptake** outside the area of the primary tumor in the lung NOTE: *Effusions visible only on CT scan and not large enough for safe thoracentesis are allowed NOTE: **If only 1 area shows an increase in FDG uptake, the area of concern requires further evaluation (e.g., biopsy) to exclude metastatic disease Bidimensionally measurable or evaluable disease* NOTE: *Lesions apparent on chest CT scan (e.g., ill-defined masses associated with post obstructive changes and mediastinal or hilar adenopathy measurable in 1 dimension) are considered evaluable PATIENT CHARACTERISTICS: Age 18 and over Performance status Not specified Life expectancy Not specified Hematopoietic WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9 g/dL Hepatic Bilirubin no greater than 1.5 mg/dL AST or ALT no greater than 1.5 times upper limit of normal Renal Creatinine no greater than 1.5 mg/dL Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Deemed medically fit for surgical resection No other active malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No psychological, sociological, or geographical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy Concurrent participation in the RPCI vaccine study (postoperative vaccination with autologous tumor-associated antigen-pulsed dendritic cells) is allowed Chemotherapy No prior chemotherapy for lung cancer No concurrent participation in another study involving other chemotherapy agents Endocrine therapy Not specified Radiotherapy No prior radiotherapy for lung cancer No concurrent participation in another study involving radiotherapy Surgery No prior surgery for lung cancer More than 3 months since other prior major surgery (e.g., coronary artery bypass graft) Other No other prior therapy for lung cancer No other concurrent antineoplastic agents Concurrent participation in observational studies requiring bloodwork, radiographs, pulmonary function tests, or quality of life studies is allowed
Sites / Locations
- Roswell Park Cancer Institute