Clinical trial NCT00301808 (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, docetaxel, 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][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [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:

          -  Histologic or cytologic diagnosis of non-small cell lung cancer (NSCLC), meeting 1 of
             the following staging criteria:

               -  Stage IIIA disease, meeting all of the following criteria:

                    -  Mediastinal lymph node involvement

                         -  Greater than one mediastinal lymph node enlarged on CT scan, confirmed
                            by positron emission tomography (PET) scan

                    -  Paralyzed left vocal cord with separate lung primary distinct from the
                       aorto-pulmonary lymph nodes on the CT scan

               -  Stage IIIB disease, meeting all of the following criteria:

                    -  N3 lymph node involvement

                         -  Enlarged N3 lymph nodes on CT scan confirmed by PET scan

                              -  Lymph node involvement may not extend to cervical lymph nodes
                                 other than supraclavicular lymph nodes

                    -  Right-sided primary tumor with left vocal cord paralysis

                    -  Evidence of tumor extension into the mediastinum and/or mediastinal
                       structures by mediastinoscopy, bronchoscopy, or CT scan

                    -  No evidence of malignant pleural effusion unless effusion is only evident on
                       CT scan

                    -  No more than 1 parenchymal lesions on the same or opposite sides of the lung

          -  No brain metastases by CT scan or MRI

        PATIENT CHARACTERISTICS:

          -  SWOG performance status 0 or 1

          -  Platelet count ≥ 100,000/mm³

          -  Absolute neutrophil count ≥ 1,500/mm³

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

          -  Creatinine clearance ≥ 45 mL/min

          -  Bilirubin normal

          -  Transaminases (SGOT and/or SGPT) ≤ 1.5 times ULN

          -  Alkaline phosphatase ≤ 2.5 times ULN

          -  Total lung volume (i.e., right and left lung minus the gross tumor volume) receiving
             greater than 20 Gy of radiation ≤ 40%

          -  FEV_1 ≥ 70% of predicted

          -  DLCO ≥ 50 mL/min

          -  No other concurrent malignancy

               -  Prior malignancy allowed provided it is in clinical control and is not likely to
                  impact clinical outcome in the opinion of the treating physician

          -  No peripheral neuropathy ≥ grade 2

          -  No serious medical illness, including, but not limited to, any of the following:

               -  Uncontrolled congestive heart failure

               -  Uncontrolled angina

               -  Myocardial infarction

               -  Cerebrovascular event within the past 6 months

               -  History of chronic active hepatitis

               -  History of HIV infection

               -  Active bacterial infection

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Must be willing and able to take folic acid, cyanocobalamin (vitamin B12), or
             dexamethasone

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy or radiotherapy for NSCLC

          -  No concurrent participation in another therapeutic investigational study

          -  Concurrent ibuprofen (400 mg four times daily) allowed during pemetrexed disodium
             administration provided the patient has normal renal function

          -  No concurrent aspirin or other nonsteroidal antiinflammatory drugs (NSAIDs) 2 days
             before, during, and for 2 days after pemetrexed disodium administration

               -  Patients on long-acting NSAIDs (e.g. naproxen sodium, diflunisal, nabumetone, or
                  celecoxib) must be willing or able to discontinue usage 5 days prior to, during,
                  and for 2 days after pemetrexed disodium administration