Clinical trial NCT00227539 (phase 2, status: completed)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: cisplatin, pemetrexed disodium
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, [H][C@@](CCC(O)=O)(NC(=O)C1=CC=C(CCC2=CNC3=C2C(O)=NC(=N)N3)C=C1)C(O)=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

          -  Stage IB, II, IIIA, or IIIB (T4, N0-1) disease

               -  Staging must have been performed 4 weeks prior to study entry with a CT scan of
                  chest, upper abdomen, and fludeoxyglucose F 18 (^18FDG) positron emission
                  tomography (PET) scan

               -  Mediastinal evaluation and staging based on combination of CT scan and FDG-PET
                  results

          -  If N1 or N2 nodes are found by FDG-PET or CT scan, metastases must be ruled out by
             brain MRI

          -  Measurable and resectable disease

               -  T4 lesions must be resectable

          -  Eligible for curative surgery

          -  No malignant pleural effusion

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,250/mm^3

          -  Platelet count ≥ 100,000/mm^3

        Hepatic

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  AST and ALT ≤ 3.0 times ULN

        Renal

          -  Creatinine clearance ≥ 45 mL/min

        Pulmonary

          -  Adequate pulmonary reserve to undergo surgery

               -  Predicted FEV_1 > 0.8 L after resection

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after
             completion of study treatment

          -  Able to take corticosteroids

          -  Able to take folic acid or vitamin B_12 supplements

          -  No other malignancy within the past 5 years except nonmelanoma skin cancer or
             noninvasive cervical cancer

          -  No concurrent serious or uncontrolled disorder that would preclude study participation

          -  No type I diabetes mellitus

               -  Type II diabetes mellitus allowed if glucose is 80-150 mg/dL

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No concurrent immunotherapy

          -  No concurrent prophylactic filgrastim (G-CSF)

          -  No concurrent thrombopoiesis-stimulating agents

        Chemotherapy

          -  At least 5 years since prior chemotherapy

        Endocrine therapy

          -  No concurrent anticancer hormonal therapy

        Radiotherapy

          -  No prior radiotherapy to the chest

          -  No concurrent curative or palliative radiotherapy

        Surgery

          -  Not specified

        Other

          -  At least 30 days since prior non-FDA-approved or investigational agents

          -  At least 5 days since prior aspirin or other nonsteroidal anti-inflammatory agents (8
             days for long-acting agents [e.g., piroxicam])

          -  No other concurrent anticancer therapy

          -  No other concurrent investigational agents