ILX-295501 in Treating Patients With Stage III or Stage IV Ovarian Cancer That Has Not Responded to Previous Treatment
- Conditions
- Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity CancerMetastatic Cancer
- Registration Number
- NCT00005645
- Lead Sponsor
- Genzyme, a Sanofi Company
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
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
🇺🇸Saint Louis, Missouri, United States
Billings Oncology Associates
🇺🇸Billings, Montana, United States
Sarah Cannon-Minnie Pearl Cancer Center
🇺🇸Nashville, Tennessee, United States
St. Vincents Comprehensive Cancer Center
🇺🇸New York, New York, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States