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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multi-Center Phase II Study of the Halichondrin B Analog E7389 in Recurrent Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

Conditions
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Fallopian Tube Cancer, Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

Intervention / Treatment
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* Drug: eribulin mesylate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (chemotherapy)<br>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. | Drug: eribulin mesylate<br>* Given IV<br>* Other names: halichrondrin B analog;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer. | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | up to a total of a year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity Profile of Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer | Measured by NCI CTCAE Version 4.0. The 95% confidence intervals should be provided. Please see adverse events. | From the time of their first treatment with eribulin mesylate |