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