Eribulin Mesylate in Treating Patients With Recurrent Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer

PRIMARY OBJECTIVES:

I. Determine the frequency of objective response (complete and partial responses) in patients
with recurrent ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer
treated with E7389 (eribulin mesylate).

SECONDARY OBJECTIVES:

II. Determine the toxicity profile of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior platinum
sensitivity (yes vs no).

Patients receive eribulin mesylate intravenously (IV) over 15 minutes on days 1 and 8.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 4 weeks.

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