A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Advanced Ovarian, Tubal, or Peritoneal Cancer Refractory to Platinum, Taxane and Topotecan
OBJECTIVES: I. Determine the antitumor activity of DX-8951f in patients with recurrent,
metastatic, or unresectable ovarian, tubal, or peritoneal carcinoma that is refractory to
platinum, taxane, and topotecan. II. Evaluate the quantitative and qualitative toxic effects
of this regimen in these patients. III. Evaluate the pharmacokinetics of this regimen in
OUTLINE: Patients are stratified by prior chemotherapy (minimally pretreated vs heavily
pretreated). Patients receive intravenous DX-8951f over 30 minutes daily for 5 days. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until death.
PROJECTED ACCRUAL: Approximately 37 patients will be accrued for this study.
Primary Purpose: Treatment
Robert L. DeJager, MD, FACP
Daiichi Sankyo Inc.
United States: Federal Government
|University of Texas - MD Anderson Cancer Center
|Houston, Texas 77030-4009