Eribulin Mesylate as Second-Line Therapy for Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer Patients

Inclusion Criteria

• •Histologically/cytologically confirmed pancreatic carcinoma (locally advanced, unresectable or metastatic)
• •measurable disease (at least 1 lesion accurately measured in at least 1 dimension (longest diameter as \>20mm with conventional techniques or \>10mm with spiral CT scan)
• •\>=4 weeks from any major surgery
• •Up to 1 prior line of gemcitabine based systemic therapy (single agent/combination therapy) for locally advanced/metastatic disease with evidence of disease progression. Prior therapy with inhibitors of angiogenesis and/or the epidermal growth factor receptor permitted. Last chemotherapy dose \>=4 weeks prior to randomization.
• •May have received prior 5FU (+/- folinic acid)/gemcitabine given concurrently with radiation as a "radiation sensitizer". Last chemotherapy dose \>=4 weeks prior to randomization.
• •Prior radiation treatment \>=4 weeks prior to randomization
• •Age \>18 years.
• •Life expectancy \>=3 months
• •ECOG\< 2(Karnofsky-60%)
• •leukocytes\>3,000/mcL
• •absolute neutrophil count\>1,500/mcL
• •platelets\>100,000/mcL
• •total bilirubin \< 1.5 UNL
• •AST/ALT≤2.5x institutional ULN
• •creatinine within institution limits OR creatinine clearance\>60mL/min/1.73m2 for patients with creatinine levels above institution limits
• •concurrent use of inhibitors/inducers of CYP3A4 are prohibited during the study treatment period
• •effects of E7389 on developing human fetus are unknown. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
• •Ability to understand/willingness to sign written informed consent