Dasatinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

This is an interventional treatment trial for Non-small Cell Lung Cancer Read More

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