A Multi-Center Phase II Study of the Halichondrin B Analog E7389 in Recurrent Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
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).
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (CR + PR) to treatment with eribulin mesylate in patients with recurrent ovarian, fallopian tube, or peritoneal cancer
Evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Reported separately for patients with platinum-resistant disease and potentially platinum-sensitive disease. The 95% confidence intervals should be provided.
Baseline and every 6 weeks
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan Kettering Cancer Center||New York, New York 10021|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|