A Multi-Center Phase II Study of the Halichondrin B Analog E7389 in Recurrent Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
Overview
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 74
- Locations
- 2
- Primary Endpoint
- Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer.
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment (chemotherapy)
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: eribulin mesylate (Drug)
Outcomes
Primary Outcomes
Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer.
Time Frame: 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 Outcomes
- 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)