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

Fallopian Tube Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00334893
• Other study ID #: NCI-2009-00169
• Secondary ID: NCI-2009-00169MS
• Status: Completed
• Phase: Phase 2
• First received: June 7, 2006
• Last updated: October 24, 2017
• Start date: April 2006
• Est. completion date: March 2012

Study information

• Verified date: October 2017
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT01645592
• NCT01664403

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms
• Primary Peritoneal Cavity Cancer
• Recurrent Ovarian Epithelial Cancer

Intervention

Drug:
• eribulin mesylate
Given IV

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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