A Multi-Center Phase II Study of the Halichondrin B Analog E7389 in Recurrent Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
OBJECTIVES:
Primary
- 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.
Secondary
- 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 E7389 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.
PROJECTED ACCRUAL: A total of 74 patients will be accrued for this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Objective response rate
No
Martee L. Hensley, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
Unspecified
CDR0000481534
NCT01664403
April 2006
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