Dasatinib in Treating Patients With Metastatic Pancreatic Cancer
Condition: Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage IV Pancreatic Cancer
MeSH terms: Adenocarcinoma; Pancreatic Neoplasms
Intervention: dasatinib; laboratory biomarker analysis; physiologic testing
Intervention description: Correlative study; Correlative study
Intervention MeSH terms: Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
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
      metastatic pancreatic cancer.
    

Eligibility criteria:

        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