Clinical trial NCT00616031 (phase 2, status: unknown status)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: carboplatin, nitroglycerin, paclitaxel
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, COC(=O)C1=C(C)NC(C)=C(C1C1=CC(=CC=C1)[N+]([O-])=O)C(=O)OCCN(C)CC1=CC=CC=C1, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed non-small cell lung cancer

               -  Stage IIIB or IV disease that cannot be treated by radical irradiation

          -  Tumor lesions must be objectively evaluated according to WHO criteria (maximum
             diameter is no shorter than twice the slice width and no shorter than 10 mm) by CT
             scan

          -  No brain metastasis

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Life expectancy ≥ 3 months

          -  Neutrophil count > 2,000/μL

          -  Hemoglobin > 10.0 g/dL

          -  Platelet count > 100,000/μL

          -  Serum bilirubin < 2.0 mg/dL

          -  ALT and AST < 100 IU/L

          -  Serum creatinine < 2.0 mg/dL

          -  PaO_2 ≥ 70 mm Hg

          -  No cardiac problems, including any of the following:

               -  Poorly controlled hypertension

               -  Unstable angina

               -  Congestive heart failure

               -  Myocardial infarction within the past year

               -  Ventricular arrhythmia that requires treatment except single, well-controlled
                  isolated ventricular extrasystole

          -  No chronic active hepatitis or cirrhosis requiring treatment except hepatitis virus
             carriers who do not need treatment

          -  No comorbidity of interstitial pneumonia and pulmonary fibrosis requiring treatment

          -  No other cancer requiring treatment except a malignant tumor curatively resected with
             no recurrence

          -  No severe psychiatric disorders including schizophrenia or dementia

          -  Cardiothoracic ratio < 60% by chest x-ray

          -  No history of severe drug allergy or allergy to polyoxyethylene castor oil (in some
             anesthetic drugs or muscle relaxants) or polysorbate 80

          -  Patients in whom nitroglycerin preparations are contraindicated are not eligible,
             including any of the following:

               -  Severe hypotension (e.g., systolic blood pressure ≤ 80 mm Hg)

               -  Angle-closure glaucoma

               -  History of hypersensitivity to nitrate/nitrite ester drugs

          -  Not pregnant or nursing

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy or radiotherapy

               -  Pleurodesis is not considered chemotherapy

          -  At least 1 week since prior and no other concurrent nitric oxide donors (e.g.,
             nitroglycerin)

          -  At least 1 week since prior and no concurrent calcium antagonists

          -  At least 1 week since prior and no concurrent drugs for erectile dysfunction that
             inhibit phosphodiesterase 5 (e.g., sildenafil citrate or vardenafil hydrochloride
             hydrate)

          -  More than 24 hours since prior and no concurrent administration of the following:

               -  Antifungal azoles, including ketoconazole, miconazole, or itraconazole

               -  Macrolides, including erythromycin or clarithromycin

               -  Cyclosporines

               -  Benzodiazepines, including diazepam, triazolam, or midazolam

               -  Vitamin A

               -  Steroid hormones, including ethinylestradiol

          -  No concurrent participation in another clinical trial