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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2012-03-31

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.

Conditions

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Fallopian Tube Cancer Primary Peritoneal Cavity Cancer Recurrent Ovarian Epithelial Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

eribulin mesylate

Intervention Type DRUG

Given IV

Interventions

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eribulin mesylate

Given IV

Intervention Type DRUG

Other Intervention Names

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B1939 E7389 ER-086526 halichrondrin B analog

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martee Hensley

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

References

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Hensley ML, Kravetz S, Jia X, Iasonos A, Tew W, Pereira L, Sabbatini P, Whalen C, Aghajanian CA, Zarwan C, Berlin S. Eribulin mesylate (halichondrin B analog E7389) in platinum-resistant and platinum-sensitive ovarian cancer: a 2-cohort, phase 2 study. Cancer. 2012 May 1;118(9):2403-10. doi: 10.1002/cncr.26569. Epub 2011 Sep 20.

Reference Type DERIVED

PMID: 21935916 (View on PubMed)