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 3,000/mcL
• absolute neutrophil count>1,500/mcL
• platelets>100,000/mcL
• total bilirubin 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

Exclusion Criteria

• chemotherapy/radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• May not be receiving other investigational agents
• Known brain metastases
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to E7389
• Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study
• Pregnant women excluded because E7389 is an antitubulin agent with the potential for teratogenic/abortifacient effects
• HIV-positive patients on combination antiretroviral therapy are ineligible because of potential for p PK interactions with E7389
• Other active malignancies in past 5 years except for cervical carcinoma in situ and non-melanomatous skin cancer