Spots Global Cancer Trial Database for ILX-295501 in Treating Patients With Stage III or Stage IV Ovarian Cancer That Has Not Responded to Previous Treatment
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Trial Identification
Brief Title: ILX-295501 in Treating Patients With Stage III or Stage IV Ovarian Cancer That Has Not Responded to Previous Treatment
Official Title: Phase II Trial of ILX295501 Administered Orally Once Weekly x 3 Repeated Every 6 Weeks in Patients With Stage III/IV Ovarian Cancer
Study ID: NCT00005645
Interventions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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
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
Contact Details
Name: Gayle Cook, RN
Affiliation: Genzyme, a Sanofi Company
Role: STUDY_CHAIR
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