Dasatinib in Treating Patients With Metastatic Pancreatic Cancer

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas
• Metastatic disease
• Measurable or evaluable/nonmeasurable disease
• No known brain metastases
• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
• Life expectancy > 12 weeks
• Absolute granulocyte count >= 1,500/mm^3
• Platelet count >= 100,000/mm^3
• Hemoglobin > 8.5 g/dL
• Bilirubin =< 1.5 times upper limit of normal (ULN)
• AST and ALT =< 2.5 times ULN
• Creatinine =< 2.0 mg/dL
• Not pregnant or nursing
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to dasatinib
• No QTc prolongation (i.e., QTc interval >= 480 msecs [Fridericia correction]) or other significant ECG abnormalities
• LVEF normal by MUGA scan

• No condition that impairs ability to swallow and retain dasatinib tablets, including any of the following:

  • Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
  • Prior surgical procedures affecting absorption
  • Active peptic ulcer disease

• No clinically significant cardiovascular disease, including any of the following:

  • Myocardial infarction or ventricular tachyarrhythmia within the past 6 months
  • Major conduction abnormality (unless a cardiac pacemaker is present)
• Recovered from all prior therapy
• More than 4 weeks since prior adjuvant chemotherapy (6 weeks for nitrosoureas or mitomycin C) and/or radiotherapy
• No prior chemotherapy for metastatic disease
• More than 4 weeks since prior EGFR inhibitors (e.g., imatinib mesylate, gefitinib, erlotinib hydrochloride, or lapatinib ditosylate)
• No prior EGFR inhibitors that target Src kinases
• At least 7 days since prior and no concurrent agents with proarrhythmic potential
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No concurrent grapefruit or grapefruit juice
• No other concurrent anticancer agents or therapies
• No concurrent systemic antacids (i.e., H2-receptor antagonists and proton pump inhibitors) [Locally acting antacids (e.g., Maalox, Mylanta) allowed within either 2 hours before or 2 hours after dasatinib therapy]

• No concurrent uncontrolled illness, including, but not limited to, any of the following:

  • Ongoing or active infection
  • History of significant bleeding disorder, including congenital (von Willebrand's disease) or acquired (anti-factor VIII antibodies) disorders
  • Large pleural effusions
  • Psychiatric illness or social situation that would preclude study compliance
• More than 7 days since prior and no concurrent CYP3A4 inducers or inhibitors
• No other concurrent investigational agents