Dasatinib in Treating Patients With Stage IV Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: dasatinib; immunoenzyme technique; immunohistochemistry staining method; laboratory biomarker analysis; quality-of-life assessment
Intervention MeSH terms: Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage IV pancreatic 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
      stage IV pancreatic cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically* confirmed pancreatic cancer

               -  Stage IV disease NOTE: *If biopsy was performed at an outside facility, the
                  histology must be reviewed and confirmed by the Division of Pathology at the City
                  of Hope

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status 60-100%

          -  Life expectancy ≥ 3 months

          -  Platelet count ≥ 100,000/μL

          -  Absolute neutrophil count ≥ 1,500/μL

          -  Bilirubin ≤ 1.5 mg/dL

          -  ALT and AST ≤ 2.5 times upper limit of normal (ULN)

          -  Creatinine ≤ 1.5 mg/dL and/or creatinine clearance > 60 mL/min

          -  PT and PTT ≤ 1.5 times ULN

          -  Able to swallow dasatinib whole

          -  No other malignancy within the past 5 years except nonmelanoma skin cancer or
             carcinoma in situ of the cervix, uterus, or bladder

          -  No concurrent medical condition which may increase the risk of toxicity, including any
             of the following:

               -  Pleural or pericardial effusion of any grade

               -  Clinically significant coagulation or platelet function disorder (e.g., known von
                  Willebrand's disease)

          -  None of the following cardiac conditions:

               -  Uncontrolled angina, congestive heart failure, or myocardial infarction within
                  the past 6 months

               -  Prolonged QTc interval (i.e., QTc > 450 msec) on electrocardiogram

               -  History of clinically significant ventricular arrhythmias (i.e., ventricular
                  tachycardia, ventricular fibrillation, or Torsades de pointes)

          -  No hypokalemia or hypomagnesemia that cannot be corrected

          -  No severe infection requiring treatment

          -  Completely recovered from other concurrent illnesses, as deemed by the investigator

          -  Not pregnant

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

          -  Recovered from prior major surgery

          -  No prior irradiation to the planned field

          -  No prior chemotherapy for pancreatic cancer

          -  At least 7 days since prior and no concurrent medications that may prolong the QT
             interval, including any of the following:

               -  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

               -  Lidoflazine

          -  At least 7 days since prior and no concurrent potent CYP3A4 inhibitors

          -  At least 7 days since prior and no concurrent medications that directly and durably
             inhibit platelet function, including any of the following:

               -  Aspirin or aspirin-containing combinations

               -  Clopidogrel

               -  Dipyridamole

               -  Tirofiban

               -  Dipyridamole

               -  Epoprostenol

               -  Eptifibatide

               -  Cilostazol

               -  Abciximab

               -  Ticlopidine

               -  Cilostazol

          -  No concurrent anticoagulants, including warfarin or heparin/low molecular weight
             heparin (e.g., danaparoid, dalteparin, tinzaparin, or enoxaparin)

               -  Low-dose warfarin for prophylaxis to prevent catheter thrombosis or heparin for
                  flushes of IV lines allowed

          -  No concurrent IV bisphosphonates during the first 8 weeks of dasatinib therapy

          -  No concurrent Hypericum perforatum (St. Johns wort)