Phase II Nonrandomized Study of LY353381-HC1 in Patients With Recurrent or Advanced Endometrial Cancer
OBJECTIVES: I. Determine the objective tumor response rate (complete response and partial
response) to arzoxifene hydrochloride in patients with recurrent or advanced endometrial
cancer. II. Determine the time to progressive disease, time to treatment failure, response
duration, and survival in patients with recurrent or advanced endometrial cancer receiving
arzoxifene hydrochloride. 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).
Primary Purpose: Treatment
Paul Sabbatini, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Lineberger Comprehensive Cancer Center, UNC||Chapel Hill, North Carolina 27599-7295|
|Arthur G. James Cancer Hospital - Ohio State University||Columbus, Ohio 43210|
|Abington Memorial Hospital||Abington, Pennsylvania 19001|
|Ellis Fischel Cancer Center - Columbia||Columbia, Missouri 65203|
|University of Oklahoma Health Sciences Center||Oklahoma City, Oklahoma 73104|
|Washington University Barnard Cancer Center||Saint Louis, Missouri 63110|
|Grant/Riverside Methodist Hospitals||Columbus, Ohio 43214|
|U.S. Oncology||Houston, Texas 77060|
|Huntington Memorial Hospital||Pasadena, California 91109-7013|