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

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