Ovarian Cancer Clinical Trial
Official title:
Phase II Study of LY353381-HC1 Administered to Women With Refractory Ovarian Cancer
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.
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).
;
Primary Purpose: Treatment
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