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Phase II Study of LY353381-HC1 Administered to Women With Refractory Ovarian Cancer (NCT00003670)

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

    4 locations

    United States (4)
    • Ellis Fischel Cancer Center - Columbia
      Not specified
      Columbia, Missouri, United States, 65203
    • Lineberger Comprehensive Cancer Center, UNC
      Not specified
      Chapel Hill, North Carolina, United States, 27599-7295
    • Abington Memorial Hospital
      Not specified
      Abington, Pennsylvania, United States, 19001
    • University of Texas - MD Anderson Cancer Center
      Not specified
      Houston, Texas, United States, 77030
    30 September, 1998
    05 June, 2012
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