Clinical trial NCT00062439 (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, etoposide
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, OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed non-small cell lung cancer

               -  Any of the following stages due to involvement of the superior sulcus:

                    -  Stage IIB (T3, N0), IIIA (T3, N1), or IIIB (T4, N0-1)

               -  Newly diagnosed

               -  Primary bronchogenic

          -  Must meet 1 of the following tumor involvement criteria:

               -  An apical tumor associated with the Pancoast syndrome (arm or shoulder pain
                  and/or neurologic findings corresponding to the roots of C-8 and/or T-1 or the
                  inferior trunk of the bronchial plexus with or without Horner's syndrome) without
                  rib or vertebral body involvement

               -  Superior sulcus tumors with involvement of the chest wall (T3), usually ribs 1
                  and 2 by CT scan or MRI, with or without an associated Pancoast syndrome

               -  Superior sulcus tumors with invasion of the vertebral bodies or involvement of
                  the subclavian vessels (T4) by CT scan or MRI, with or without an associated
                  Pancoast syndrome

          -  No more than 1 parenchymal lesion in the same lung or in both lungs

          -  No involvement of the following lymph node groups as determined by mediastinal
             exploration* (i.e., mediastinoscopy, mediastinotomy, thoracoscopy, or thoracotomy)
             within the past 42 days:

               -  Single-level or multi-level ipsilateral or contralateral mediastinal nodal (N2 or
                  N3) disease by mediastinoscopy, thoracoscopy, mediastinotomy, thoracotomy, or
                  transbronchial Wang needle biopsy, regardless of whether enlarged nodes are
                  visible or not on chest x-ray or CT scan

               -  Supraclavicular (scalene) nodes

                    -  Any nodes evident on physical exam must be biopsied by fine needle
                       aspiration or open biopsy

               -  Left upper lobe tumors with left vocal cord paralysis by indirect laryngoscopy
                  (presumes N2 nodes in the A-P window) NOTE: *Mediastinal exploration is not
                  required for patients whose mediastinum is negative by both positron-emission
                  tomography (PET) and CT scan

          -  No pleural effusions except if 1 of the following criteria are met:

               -  Pleural effusion present before mediastinoscopy or thoracotomy with negative
                  cytology on 2 separate thoracenteses

               -  Pleural effusion present only after exploratory or staging thoracotomy, with
                  negative cytology on a single thoracentesis

               -  Present only on CT scan and too small to tap

          -  No pericardial effusions or superior vena cava syndrome

          -  No brain metastases by CT scan or MRI

          -  No evidence of distant metastatic disease by bone scan or PET

          -  Must be a candidate for potential future pulmonary resection

        PATIENT CHARACTERISTICS:

        Age

          -  Not specified

        Performance status

          -  Zubrod 0-2

               -  Patients with Zubrod performance status 2 must have an albumin level at least
                  0.85 times lower limit of normal and weight loss no greater than 10%

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)*

          -  SGOT or SGPT no greater than 1.5 times ULN* NOTE: *Unless due to a documented benign
             disease

        Renal

          -  Creatinine clearance at least 50 mL/min

        Cardiovascular

          -  No myocardial infarction within the past 3 months

          -  No active angina

          -  No unstable heart rhythms

          -  No clinically evident congestive heart failure

        Pulmonary

          -  Preresection FEV_1 at least 2.0 L OR

          -  Predicted postresection FEV_1 greater than 1.0 L

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No uncontrolled peptic ulcer disease

          -  No grade 2 or greater sensory neuropathy

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer or carcinoma in situ of the cervix

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No concurrent colony-stimulating factors during chemoradiotherapy or course 1 of
             consolidation therapy

        Chemotherapy

          -  No prior chemotherapy for lung cancer

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior radiotherapy to the neck or thorax

          -  No concurrent intensity-modulated radiotherapy

        Surgery

          -  Prior exploratory thoracotomy allowed only for diagnosis or staging purposes

        Other

          -  No concurrent amifostine