Eribulin Mesylate as Second-Line Therapy for Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer Patients
Condition: Adenocarcinoma of the Pancreas; Pancreatic Cancer; Recurrent Pancreatic Cancer; Stage II Pancreatic Cancer; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: eribulin mesylate
Intervention description: Given IV
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well E7389 works as second-line therapy in treating
      patients with locally advanced, unresectable, or metastatic pancreatic cancer. Drugs used in
      chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor
      cells, either by killing the cells or by stopping them from dividing.
    

Eligibility criteria:

        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

        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