Eribulin Mesylate in Treating Patients With Recurrent Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer
Fallopian Tube Cancer, Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer
About this trial
This is an interventional treatment trial for Fallopian Tube Cancer
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
Sites / Locations
- Dana-Farber Cancer Institute
- Memorial Sloan-Kettering Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (chemotherapy)
Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.