NCT00334893

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2006

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2006

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

December 10, 2013

Completed
Last Updated

November 29, 2017

Status Verified

October 1, 2017

Enrollment Period

5.9 years

First QC Date

June 7, 2006

Results QC Date

October 16, 2013

Last Update Submit

October 24, 2017

Conditions

Fallopian Tube CancerPrimary Peritoneal Cavity CancerRecurrent Ovarian Epithelial Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    From the time of their first treatment with eribulin mesylate

Study Arms (1)

Treatment (chemotherapy)

EXPERIMENTAL

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

Interventions

eribulin mesylateDRUG

Given IV

Also known as: B1939, E7389, ER-086526, halichrondrin B analog
Treatment (chemotherapy)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +23 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

  • 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.

    PMID: 21935916DERIVED

MeSH Terms

Conditions

Fallopian Tube NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

eribulin

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFallopian Tube DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeOvarian NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal Disorders

Results Point of Contact

Title
Dr. Martee L. Hensley
Organization
Memorial Sloan-Kettering Cancer Center
hensleym@mskcc.org
646-888-4222

Study Officials

  • Martee Hensley

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2006

First Posted

June 8, 2006

Study Start

April 1, 2006

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

November 29, 2017

Results First Posted

December 10, 2013

Record last verified: 2017-10

Locations

US(2)