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

Brief Title

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

Official Title

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

Brief 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.

Detailed 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.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer.

Secondary Outcome

 Toxicity Profile of Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer

Condition

Fallopian Tube Cancer

Intervention

eribulin mesylate

Study Arms / Comparison Groups

 Treatment (chemotherapy)

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

April 2006

Completion Date

March 2012

Primary Completion Date

March 2012

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

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Martee Hensley, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00334893

Organization ID

NCI-2009-00169

Secondary IDs

NCI-2009-00169

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)

Study Sponsor

Martee Hensley, Principal Investigator, Memorial Sloan Kettering Cancer Center

Verification Date

October 2017