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|
|Barnes-Jewish Hospital||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|