Eribulin Mesylate in Treating Patients With Recurrent Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer
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
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Recurrent Ovarian Epithelial Cancer
Drug: eribulin mesylate
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multi-Center Phase II Study of the Halichondrin B Analog E7389 in Recurrent Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer|
- Objective response rate (CR + PR) to treatment with eribulin mesylate in patients with recurrent ovarian, fallopian tube, or peritoneal cancer [ Time Frame: Baseline and every 6 weeks ] [ Designated as safety issue: No ]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.
- Toxicity profile of eribulin mesylate in patients with recurrent ovarian, fallopian tube, or peritoneal cancer [ Time Frame: From the time of their first treatment with eribulin mesylate ] [ Designated as safety issue: Yes ]Measured by NCI CTCAE Version 4.0. The 95% confidence intervals should be provided.
|Study Start Date:||April 2006|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Experimental: 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.
Drug: eribulin mesylate
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.
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Martee Hensley||Memorial Sloan-Kettering Cancer Center|