Phase II Trial of ILX295501 Administered Orally Once Weekly x 3 Repeated Every 6 Weeks in Patients With Stage III/IV Ovarian Cancer
OBJECTIVES: I. Determine the objective response in patients with refractory stage III or IV
ovarian epithelial cancer treated with ILX-295501. II. Determine the number of patients with
at least 50% decrease in CA125 when treated with this regimen. III. Determine the time to
tumor progression, overall survival, and toxicity profile in this patient population treated
with this regimen.
OUTLINE: This is a multicenter study. Patients receive oral ILX-295501 once weekly for 3
weeks. Treatment repeats every 6 weeks for a maximum of 6 courses in the absence of disease
progression or unacceptable toxicity. Patients are followed at 1 month and then every 3
months until death.
PROJECTED ACCRUAL: A total of 30-50 patients will be accrued for this study.
Primary Purpose: Treatment
Gayle Cook, RN
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA
|Los Angeles, California 90095-1781
|Indiana University Cancer Center
|Indianapolis, Indiana 46202-5265
|Saint Louis, Missouri 63110
|Sarah Cannon-Minnie Pearl Cancer Center
|Nashville, Tennessee 37203
|Virginia Mason Medical Center
|Seattle, Washington 98111
|St. Vincents Comprehensive Cancer Center
|New York, New York 10011
|Mercy Medical Center, Inc.
|Baltimore, Maryland 21202
|Billings Oncology Associates
|Billings, Montana 59101