ILX-295501 in Treating Patients With Stage III or Stage IV Ovarian Cancer That Has Not Responded to Previous Treatment
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|ClinicalTrials.gov Identifier: NCT00005645|
Recruitment Status : Unknown
Verified February 2001 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : May 26, 2004
Last Update Posted : January 6, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Cancer Metastatic Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer||Drug: ILX-295501||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|