Hormone Therapy With Arzoxifene Hydrochloride in Treating Women With Metastatic Refractory Ovarian Cancer or Primary Peritoneal Cancer
|ClinicalTrials.gov Identifier: NCT00003670|
Recruitment Status : Completed
First Posted : May 21, 2004
Last Update Posted : June 7, 2012
RATIONALE: Estrogen can stimulate the growth of ovarian cancer cells. Hormone therapy using arzoxifene hydrochloride may fight ovarian or peritoneal cancer by blocking the use of estrogen by the tumor cells.
PURPOSE: This phase II trial is studying how well arzoxifene hydrochloride works in treating women with metastatic refractory ovarian cancer or primary peritoneal cancer.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Primary Peritoneal Cavity Cancer||Drug: arzoxifene hydrochloride||Phase 2|
OBJECTIVES: I. Evaluate response rate to arzoxifene hydrochloride in patients with metastatic refractory ovarian epithelial cancer or primary peritoneal cancer. II. Determine the time to progressive disease, time to treatment failure, response duration, and survival of these patients. III. Assess the safety of this treatment in these patients. IV. Measure changes in serum estradiol, follicle stimulating hormone, luteinizing hormone, and sex hormone binding globulin during this treatment in these patients.
OUTLINE: Patients receive oral arzoxifene hydrochloride daily at a fixed dose. Treatment continues in the absence of unacceptable toxicity or disease progression.
PROJECTED ACCRUAL: Not specified
National Cancer Institute (NCI) registered this trial with Eli Lilly as sponsor. NCI did not update the record when the trial completed. In June 2012, NCI transferred the trial to Lilly's clinicaltrials.gov account and Lilly updated the record with the trial completion date. This trial is not an applicable trial under Food and Drug Administration Amendments Act of 2007 (FDAAA).
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Study of LY353381-HC1 Administered to Women With Refractory Ovarian Cancer|
|Study Start Date :||October 1998|
|Study Completion Date :||January 2001|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003670
|United States, Missouri|
|Ellis Fischel Cancer Center - Columbia|
|Columbia, Missouri, United States, 65203|
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center, UNC|
|Chapel Hill, North Carolina, United States, 27599-7295|
|United States, Pennsylvania|
|Abington Memorial Hospital|
|Abington, Pennsylvania, United States, 19001|
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Andrzej P. Kudelka, MD||M.D. Anderson Cancer Center|