Pemetrexed Disodium and Cisplatin in Treating Patients Who Are Undergoing Surgery for Stage I, Stage II, or 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, stage IIIB non-small cell lung cancer, stage II non-small cell lung cancer, stage I non-small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Microscopically confirmed non-small cell lung cancer Stage IB (T2, N0, M0), IIA (T1, N1, M0), IIB (T2, N1, M0 or T3, N0, M0), or IIIA (T1-3, N1-2, M0) disease Satellite lesions in one lobe (T4) (stage IIIB) allowed Meets 1 of the following criteria: Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 10 mm in the longest diameter Evaluable disease, defined as lesions on chest CT scan that are not measurable (e.g., ill-defined masses or mediastinal or hilar adenopathy) No metastatic disease except peribronchial/hilar lymph nodes (N1) or ipsilateral/subcarinal mediastinal lymph nodes (N2) No N3 lymph nodes (e.g., contralateral mediastinal/hilar or supraclavicular/scalene) by CT scan or positron emission tomography (PET) scan AND mediastinoscopy No T4 primary tumor (e.g., mediastinal invasion) No malignant pleural effusion Nonmalignant effusions (i.e., negative cytology, non-bloody, and transudate) allowed Effusions visible only by CT scan and not large enough for safe thoracentesis allowed No exudative effusion, defined by 1 of the following criteria: Pleural fluid protein:serum protein ratio > 0.5 Pleural fluid lactic dehydrogenase (LDH):serum LDH ratio ≥ 0.6 Pleural fluid LDH > 200 IU/L No more than 1 area of fludeoxyglucose (FDG) uptake outside the area of the primary lung tumor OR evidence of malignant pleural disease as evidenced by pleural nodules by PET scan Single areas of FDG uptake will be further evaluated (e.g., by biopsy) for metastatic disease PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic WBC ≥ 3,000/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9 g/dL Hepatic Bilirubin ≤ 1.5 mg/dL SGOT or SGPT ≤ 1.5 times upper limit of normal Renal Creatinine clearance ≥ 45 mL/min Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study treatment No other active malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No psychological, familial, sociological, or geographical situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for lung cancer Endocrine therapy Not specified Radiotherapy No prior radiotherapy for lung cancer Surgery No prior surgery for lung cancer At least 12 weeks since prior major surgery to the chest and abdomen Other No concurrent aspirin or other nonsteroidal anti-inflammatory drugs for ≥ 2 days before (5 days for drugs with a long half-life [e.g., naproxen, piraoxicam, difunisal, nabumetone, rofecoxib, or celecoxib] or 8 days for long acting agents), during, and for 2 days after completion of each pemetrexed disodium administration No concurrent participation in another study involving chemotherapy or radiotherapy
Sites / Locations
- Roswell Park Cancer Institute
Arms of the Study
Arm 1
Experimental
Neoadjuvant chemotherapy
Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses