Ovarian Cancer Clinical Trial
Eribulin Mesylate in Treating Patients With Recurrent Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer
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.
Full Description
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.
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
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There are 2 Locations for this study
Boston Massachusetts, 02115, United States
New York New York, 10065, United States
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