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Phase II Nonrandomized Study of LY353381-HC1 in Patients With Recurrent or Advanced Endometrial Cancer (NCT00003669)

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.
  • Drug: arzoxifene hydrochloride
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    Accepts Healthy Volunteers
    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).

    10 locations

    United States (10)
    • Huntington Memorial Hospital
      Not specified
      Pasadena, California, United States, 91109-7013
    • Ellis Fischel Cancer Center - Columbia
      Not specified
      Columbia, Missouri, United States, 65203
    • Washington University Barnard Cancer Center
      Not specified
      Saint Louis, Missouri, United States, 63110
    • Memorial Sloan-Kettering Cancer Center
      Not specified
      New York, New York, United States, 10021
    • Lineberger Comprehensive Cancer Center, UNC
      Not specified
      Chapel Hill, North Carolina, United States, 27599-7295
    • Arthur G. James Cancer Hospital - Ohio State University
      Not specified
      Columbus, Ohio, United States, 43210
    • Grant/Riverside Methodist Hospitals
      Not specified
      Columbus, Ohio, United States, 43214
    • University of Oklahoma Health Sciences Center
      Not specified
      Oklahoma City, Oklahoma, United States, 73190
    • Abington Memorial Hospital
      Not specified
      Abington, Pennsylvania, United States, 19001
    • U.S. Oncology
      Not specified
      Houston, Texas, United States, 77060
    31 October, 1998
    05 June, 2012
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