Dasatinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer; Recurrent Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: dasatinib
Intervention description: Given orally
Intervention MeSH terms: Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell
      growth. This phase II trial is studying how well dasatinib works in treating patients with
      stage IIIB, stage IV, or recurrent non-small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Platelet count >= 100,000/mm^3

          -  Histologically or cytologically confirmed non-small cell lung cancer meeting 1 of the
             following criteria:

               -  Stage IV disease

               -  Stage IIIB disease with pleural effusion

               -  Recurrent disease after surgery or radiotherapy

          -  Measurable disease, defined as >= 1 lesion that can be accurately measured in at least
             1 dimension (longest diameter to be recorded) >= 20 mm by conventional techniques OR
             >= 10 mm by spiral CT scan

          -  Previously treated brain metastasis allowed, provided there is no bleeding, no midline
             shift, no need for steroids or anti-convulsants, and no symptoms

          -  Must agree to obtain residual tumor tissue available from the existing diagnostic
             biopsy tumor tissue

          -  Eastern cooperative oncology group (ECOG) performance status (PS) 0-1 OR Karnofsky PS
             60-100%

          -  Life expectancy > 12 weeks

          -  White blood cell (WBC) >= 3,000/mm^3

          -  Absolute neutrophil count >= 1,500/mm^3

          -  Bilirubin =< 1.5 times upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) and ALT =< 2.5 times ULN

          -  Creatinine =< 3 times ULN OR Creatinine clearance >= 60 mL/min

          -  No uncontrolled congestive heart failure or potentially life-threatening arrhythmia

          -  No angina at rest

          -  No neuropathy >= grade 2

          -  No chronic diarrhea or history of inflammatory bowel disease

          -  No history of pulmonary fibrosis (other than in an irradiated field)

          -  No other concurrent serious medical illness

          -  O2 saturation > 92% on room air

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No history of allergic reactions to compounds of similar chemical or biological
             composition to dasatinib

          -  No heart rate-corrected QT interval (QTc) prolongation (i.e., QTC >= 480 msec) or
             other significant ECG abnormalities that could lead to adverse effects if the QTc
             interval were prolonged

          -  No medical condition that impairs the ability to swallow, retain, or absorb dasatinib
             including, but not limited to, any of the following:

               -  Gastrointestinal tract disease resulting in an inability to take oral medication,
                  requirement for IV alimentation, prior surgical procedures affecting absorption,
                  active peptic ulcer disease

          -  No myocardial infarction or ventricular tachyarrhythmia within the past 6 months

          -  left ventricular ejection fraction (LVEF) normal

          -  No major conduction abnormality (unless cardiac pacemaker is present)

          -  No ongoing or active infection

          -  No history of significant bleeding disorder (congenital [von Willebrand's disease] or
             acquired [antifactor VIII antibodies])

          -  No psychiatric illness or social situation that would preclude study compliance

          -  No prior chemotherapy or biologic therapy for recurrent or metastatic non-small cell
             lung cancer

          -  Adjuvant cytotoxic chemotherapy after surgical resection or chemotherapy with
             radiation for locally advanced disease (curative intent) allowed provided disease
             recurrence >= 3 months after completion of last chemotherapy dose

          -  Measurable disease must be outside the radiotherapy port OR clearly growing inside the
             port

          -  No prior radiotherapy to >= 25% of the marrow-containing skeleton

          -  At least 7 days since prior and no concurrent medications that are inhibitors or
             inducers of CYP3A4

          -  At least 7 days since prior and no concurrent agents with proarrhythmic potential

          -  No other concurrent investigational agents

          -  No other concurrent anticancer agents or therapies

          -  No concurrent antiretroviral therapy for HIV-positive patients

          -  No concurrent systemic antacids (H2 receptor antagonists and proton pump inhibitors)

          -  Locally acting antacids allowed except for 2 hours before and after dasatinib
             administration