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Phase II Trial of ILX295501 Administered Orally Once Weekly x 3 Repeated Every 6 Weeks in Patients With Stage III/IV Ovarian Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of ILX-295501 in treating patients who have stage III or stage IV ovarian cancer that has not responded to previous therapy.
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.
Age
18 - 120 years
Sex
FEMALE
Healthy Volunteers
No
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Mercy Medical Center, Inc.
Baltimore, Maryland, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Billings Oncology Associates
Billings, Montana, United States
St. Vincents Comprehensive Cancer Center
New York, New York, United States
Sarah Cannon-Minnie Pearl Cancer Center
Nashville, Tennessee, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Start Date
May 1, 1999
Last Updated
September 18, 2018
ILX-295501
DRUG
Lead Sponsor
Genzyme, a Sanofi Company
NCT04550494
NCT05039801
Data Source & Attribution
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