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

Phase 2

Completed

• Conditions: Fallopian Tube Cancer; Recurrent Ovarian Epithelial Cancer; Primary Peritoneal Cavity Cancer
• Interventions: Drug: eribulin mesylate

• Registration Number: NCT00334893
• Lead Sponsor: National Cancer Institute (NCI)

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 Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-06-07
• Study First Submitted QC: 2006-06-07
• Study First Posted: 2006-06-08
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Results First Submitted: 2013-10-16
• Results First Submitted QC: 2013-10-16
• Results First Posted: 2013-12-10
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 74

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (chemotherapy)	eribulin mesylate	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.

Primary Outcome Measures

Name	Time	Method
Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer.	up to a total of a year	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

Name	Time	Method
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	Measured by NCI CTCAE Version 4.0. The 95% confidence intervals should be provided. Please see adverse events.

Trial Locations

Locations (2)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States