ILX-295501 in Treating Patients With Stage III or Stage IV Ovarian Cancer That Has Not Responded to Previous Treatment
Recruitment status was: Active, not recruiting
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.
|Fallopian Tube Cancer Metastatic Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer||Drug: ILX-295501||Phase 2|
|Study Design:||Primary Purpose: 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 Start Date:||May 1999|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005645
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|United States, Indiana|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202-5265|
|United States, Maryland|
|Mercy Medical Center, Inc.|
|Baltimore, Maryland, United States, 21202|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|United States, Montana|
|Billings Oncology Associates|
|Billings, Montana, United States, 59101|
|United States, New York|
|St. Vincents Comprehensive Cancer Center|
|New York, New York, United States, 10011|
|United States, Tennessee|
|Sarah Cannon-Minnie Pearl Cancer Center|
|Nashville, Tennessee, United States, 37203|
|United States, Washington|
|Virginia Mason Medical Center|
|Seattle, Washington, United States, 98111|
|Study Chair:||Gayle Cook, RN||Genzyme, a Sanofi Company|