Eribulin Mesylate in Treating Patients With Recurrent Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer
Condition: Fallopian Tube Cancer; Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer
MeSH terms: Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial; Recurrence
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: 74.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well eribulin mesylate works in treating patients with
      recurrent ovarian epithelial, primary peritoneal cavity, or fallopian tube 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 or cytologically confirmed ovarian epithelial, primary peritoneal
             cavity, or fallopian tube cancer

               -  Recurrent disease after ≥ 1 prior therapy, meeting 1 of the following criteria:

                    -  Platinum-resistant disease (progression-free interval < 6 months)

                    -  Platinum-sensitive disease (progression-free interval ≥ 6 months)

          -  Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mmby
             conventional techniques OR ≥ 10 mm by spiral CT scan

          -  No known brain metastasis

          -  Life expectancy > 2 months

          -  ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  WBC ≥ 3,000/mm^3

          -  Bilirubin normal

          -  AST and ALT ≤ 2.5 times upper limit of normal

          -  Creatine normal OR creatinine clearance ≥ 60 mL/min

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No prior invasive malignancy within the past 5 years except nonmelanoma skin cancer

               -  Stage IA or IB endometrial cancer within the past 5 years allowed provided
                  patient is considered disease free

          -  No history of allergic reaction attributed to compounds of similar chemical or
             biological composition to E7389

          -  No HIV positivity

          -  No ongoing or active infection

          -  No cardiac arrhythmia

          -  No unstable angina pectoris

          -  No symptomatic congestive heart failure

          -  No psychiatric illness or social situations that would preclude study compliance

          -  No other uncontrolled intercurrent illness

          -  See Disease Characteristics

          -  Recovered from effects of recent surgery, radiotherapy, or chemotherapy

          -  No more than 2 prior cytotoxic therapies with no more than 1 non platinum, non taxane
             regimen

          -  No prior E7389

          -  More than 14 days since prior hormonal therapy

          -  More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)

          -  More than 4 weeks since prior radiotherapy

          -  No concurrent antitumor hormonal therapy

          -  No other concurrent investigational agents

          -  No other concurrent anticancer agents or therapies

          -  No granulocyte colony-stimulating factors during the first course of study therapy