Spots Global Cancer Trial Database for Hormone Therapy With Arzoxifene Hydrochloride in Treating Women With Metastatic Refractory Ovarian Cancer or Primary Peritoneal Cancer

Study Description

Brief Summary: 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.

Detailed Description: 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).

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial