Dasatinib in Treating Patients With Advanced Lung Cancer That Is No Longer Responding to Erlotinib or Gefitinib
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: dasatinib
Intervention MeSH terms: Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the lung; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer

Summary:

      RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth.

      PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with
      advanced lung cancer that is no longer responding to erlotinib or gefitinib.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Pathologically confirmed adenocarcinoma of the lung

               -  Advanced disease

          -  Previously treated with erlotinib hydrochloride or gefitinib for 6 months (at any
             time) and meets 1 of the following criteria:

               -  Previously received treatment with erlotinib hydrochloride or gefitinib* and had
                  a radiographic partial or complete response to treatment with erlotinib
                  hydrochloride or gefitinib as defined by RECIST or WHO criteria

               -  Documented mutation in EGFR from tumor DNA NOTE: *Patients may have received
                  other treatments subsequently including radiation or chemotherapy

          -  Must have developed acquired resistance to erlotinib hydrochloride or gefitinib

               -  Radiographic evidence of disease progression during treatment with erlotinib
                  hydrochloride or gefitinib

          -  Have previously undergone a biopsy of a site of progressive disease on protocol MSKCC
             04-103* NOTE: *Results of this biopsy are not required to be enrolled on this trial

          -  Measurable indicator lesions have not been previously irradiated

          -  No CNS lesion that is symptomatic and/or requiring escalating doses of corticosteroids

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status 70-100%

          -  WBC ≥ 3,000/mm³

          -  Hemoglobin ≥ 9.0 g/dL

          -  Platelet count ≥ 100,000/mm³

          -  Total bilirubin ≤ 2.0 mg/dL

          -  AST and ALT ≤ 2.5 times upper limit of normal

          -  Creatinine ≤ 2 mg/dL or creatinine clearance ≥ 55 mL/min

          -  QTc < 450 msec

          -  Able to take oral medications

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for at least 4 weeks
             after study drug is stopped

          -  No significant medical history or unstable medical condition, including any of the
             following:

               -  History of diagnosed congenital long QT syndrome

               -  Ventricular arrhythmia

               -  Congestive heart failure

               -  Recent myocardial infarction

               -  Unstable angina

               -  Active infection

               -  Uncontrolled hypertension

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  At least 3 weeks since prior cytotoxic chemotherapy

          -  At least 3 weeks since prior radiation therapy to a major bone-marrow containing area

          -  At least 7 days since prior quinidine, procainamide, disopyramide, amiodarone,
             sotalol, ibutilide, dofetilide, erythromycin, clarithromycin, chlorpromazine,
             haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol,
             methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine,
             sparfloxacin, or lidoflazine