Molecular and Genetic Changes in Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) Following Neoadjuvant Chemotherapy With Cisplatin and Alimta - Phase II Study

Inclusion Criteria:

- Microscopically confirmed non-small cell carcinoma of the lung

- No prior therapy for lung cancer

- Patients must have disease stages IB (T2N0M0), IIA (T1N1M0), IIB (T2N1M0 and T3N0M0),
or lIlA (T3N1M0 and T1-3N2M0); patients with satellite lesions in one lobe (T4)
(stage IIIB) will also be eligible

- Patients must be deemed surgically resectable by a thoracic surgeon

- Patients must have either measurable or evaluable disease; measurable disease: any
lesion that can be accurately measured in at least one dimension, with the longest
diameter being >= 10 mm; evaluable disease: lesions apparent on computed tomography
(CT), which do not meet the criteria for measurability; these include ill-defined
masses associated with post obstructive changes and mediastinal or hilar adenopathy

- Informed consent must be obtained

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Patients must be > 12 weeks from prior major surgery of the chest and abdomen

- Calculated creatinine clearance (CrC1) >= 45 mL/min based on the Cockcroft and Gault
formula

- The ability to take folic acid, Vitamin B12, and dexamethasone according to protocol

Exclusion Criteria:

- White bloods cell count < 3000/mm^3

- Platelet count < 100,000/mm^3

- Hemoglobin < 9 g/dl

- Calculated creatinine clearance (CrCl) < 45 mL/min based on the Cockcroft and Gault
formula

- Total bilirubin > 1.5 mg/dl

- Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvate
transaminase (SGPT) > 1.5 x upper limit of normal

- Metastatic disease (except peribronchial/hilar lymph nodes = N1 and
ipsilateral/subcarinal mediastinal lymph nodes = N2) or malignant pleural effusion
detected on preoperative evaluation; non-malignant effusions have negative cytology,
are non-bloody, and are transudates; effusions visible only on CT and not large
enough for safe thoracentesis will not result in ineligibility; exudative effusions,
even if cytologically negative are excluded; pleural fluid is considered exudative
if: the ratio of pleural fluid protein to serum protein is greater than 0.5, the
ratio of pleural fluid lactate dehydrogenase (LDH) to serum to serum LDH > 0.6,
pleural fluid LDH is greater than 200 RI/liter

- N3 lymph nodes (contralateral mediastinal/hilar and supraclavicular/scalene) or T4
primary tumor (malignant pleural effusion or mediastinal invasion) by clinical
staging criteria, (N3 as seen on CT or PET scan; patients may be eligible only if N3
nodes proven negative by mediastinoscopy and/or excisional biopsy of supraclavicular
lymph node)

- Presence of third space fluid which cannot be controlled by drainage; for patients
who develop or have baseline clinically significant pleural or peritoneal effusions
before or during initiation of pemetrexed therapy, consideration should be given to
draining the effusion prior to dosing; however, if in the investigator's opinion, the
effusion represents progression of disease then the patient should be discontinued
from study therapy

- Prior chemotherapy, surgery, or radiation therapy for lung cancer

- Pregnant or lactating

- Other active malignancy within 2 years with the exceptions of nonmelanoma skin cancer
and cervical carcinoma in situ

- Psychological, familial, sociologic or geographic conditions, which do not permit
medical follow-up and compliance with the study protocol

- Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAID)
2 days before, the day of and 2 days after the dose of Alimta (Pemetrexed); if a
patient is taking a NSAID or a salicylate with a long half-life (for example,
naproxen, piroxicam, diflunisal, nabumetone, rofecoxib, or celecoxib) it should not
be taken 5 days before the dose of Alimta (Pemetrexed); (8 day period for long acting
agents such as piroxicam), the day of, and 2 days after the dose of Alimta
(Pemetrexed)

- Squamous cell carcinoma histology

- The screening PET scan will be used to exclude patients; if there are multiple areas
of FDG uptake, outside the area of the primary tumor in the lung, or evidence of
malignant pleural disease as evidenced by pleural nodules, the patient will be
excluded by virtue of having metastatic disease; if however, only one area shows an
increase in FDG uptake, the area of concern will need further evaluation such as a
biopsy to exclude metastatic disease