Hormone Therapy With Arzoxifene Hydrochloride in Treating Women With Recurrent, Advanced, or Metastatic Endometrial Cancer
- Conditions
- Endometrial Cancer
- Registration Number
- NCT00003669
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
Grant/Riverside Methodist Hospitals
🇺🇸Columbus, Ohio, United States
U.S. Oncology
🇺🇸Houston, Texas, United States
Huntington Memorial Hospital
🇺🇸Pasadena, California, United States
Washington University Barnard Cancer Center
🇺🇸Saint Louis, Missouri, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States