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.
Interventional
Primary Purpose: Treatment
Gayle Cook, RN
Study Chair
Genzyme
United States: Federal Government
CDR0000067825
NCT00005645
May 1999
Name | Location |
---|---|
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 |