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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
eribulin mesylate
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Dana-Farber Cancer Institute
  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (chemotherapy)

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 7, 2006
Last Updated
October 24, 2017
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00334893
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (chemotherapy)
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
eribulin mesylate
Other Intervention Name(s)
B1939, E7389, ER-086526, halichrondrin B analog
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer.
Description
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.
Time Frame
up to a total of a year
Secondary Outcome Measure Information:
Title
Toxicity Profile of Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer
Description
Measured by NCI CTCAE Version 4.0. The 95% confidence intervals should be provided. Please see adverse events.
Time Frame
From the time of their first treatment with eribulin mesylate

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martee Hensley
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21935916
Citation
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.
Results Reference
derived

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

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