Clinical trial NCT00248495 (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:

          -  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