Endometrial Cancer Clinical Trial
Official title:
Phase II Nonrandomized Study of LY353381-HC1 in Patients With Recurrent or Advanced Endometrial Cancer
RATIONALE: Estrogen can stimulate the growth of endometrial cancer cells. Hormone therapy
using arzoxifene hydrochloride may fight the endometrial 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 recurrent, advanced, or metastatic 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
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