A Phase II Study of MGI-114 in Patients With Recurrent or Persistent Epithelial Ovarian Cancer
OBJECTIVES: I. Determine the clinical activity of irofulven in patients with recurrent or
persistent ovarian epithelial cancer. II. Characterize the pharmacokinetic profile of this
drug in these patients. III. Determine the pharmacodynamic relationship between plasma
concentrations and clinical activity or toxicity of this drug in these patients.
OUTLINE: Patients are stratified according to the number of prior treatment regimens (1-2 vs
3 or more). Patients receive irofulven IV over 5 minutes on days 1-5. Courses repeat every 4
weeks in the absence of disease progression or unacceptable toxicity. Patients are followed
every 4 weeks until death.
PROJECTED ACCRUAL: A maximum of 74 patients will be accrued for this study within 3 years.
Primary Purpose: Treatment
Gisele A. Sarosy, MD
National Cancer Institute (NCI)
United States: Federal Government
|Medicine Branch||Bethesda, Maryland 20892|