RATIONALE: Estrogen can stimulate the growth of endometrial cancer cells. Hormone therapy using LY353381 hydrochloride may fight the endometrial cancer by blocking the uptake of estrogen by the cancer cells. PURPOSE: Phase II trial to study the effectiveness of LY353381 hydrochloride in treating women who have recurrent, advanced, or metastatic endometrial cancer.

Condition	Treatment or Intervention	Phase
stage IV endometrial cancer recurrent endometrial cancer	Drug: LY353381 hydrochloride	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the objective tumor response rate (complete response and partial response) to LY353381 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 LY353381 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.

PROTOCOL OUTLINE: Patients receive oral LY353381 hydrochloride daily at a fixed dose. Treatment continues in the absence of unacceptable toxicity or disease progression.

PROJECTED ACCRUAL: Not specified

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed recurrent, advanced, or metastatic endometrial cancer not amenable to curative surgery or radiotherapy; Patients should have previously undergone radical surgery (minimum of total abdominal hysterectomy and bisalpingoophorectomy), radical radiotherapy, or not be candidate for such procedures
• Bidimensionally measurable disease by x-ray, CT scan, MRI, or physical exam
• No papillary serous or clear cell carcinomas of the endometrium
• Hormone receptor status: Estrogen receptor positive and/or progesterone receptor positive Unknown receptor status patients allowed provided (1) original tumor was well- or moderately-well differentiated (2) had endometrioid histology

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior chemotherapy for recurrent or metastatic endometrial cancer; At least 1 year since prior adjuvant chemotherapy
• Endocrine therapy: No prior antiestrogen therapy for any stage of endometrial cancer; At least 12 months from time of diagnosis since prior raloxifene; Prior progesterone treatment allowed
• Radiotherapy: See Disease Characteristics; At least 2 weeks since prior radiotherapy and recovered
• Surgery: See Disease Characteristics

--Patient Characteristics--

• Age: 18 and over
• Performance status: Karnofsky 70-100%
• Menopausal status: Not specified
• Life expectancy: At least 12 weeks
• Hematopoietic: Granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL (transfusion-independent); Prothrombin time or activated partial thromboplastin time no greater than 1.25 times upper limit of normal (ULN)
• Hepatic: Bilirubin no greater than 1.5 times normal; ALT or AST no greater than 2.5 times ULN (ALT and AST no greater than 5 times ULN in the presence of liver metastases)
• Renal: Creatinine no greater than 1.5 ULN
• Other: No other primary malignancy within the past 5 years except adequately treated nonmelanomatous cancer of the skin or carcinoma in situ of the cervix

California
      Huntington Memorial Hospital, Pasadena,  California,  91109-7013,  United States
Missouri
      Ellis Fischel Cancer Center - Columbia, Columbia,  Missouri,  65203,  United States
      Washington University Barnard Cancer Center, Saint Louis,  Missouri,  63110,  United States
New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
North Carolina
      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States
Ohio
      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210,  United States
      Grant/Riverside Methodist Hospitals, Columbus,  Ohio,  43214,  United States
Oklahoma
      University of Oklahoma Health Sciences Center, Oklahoma City,  Oklahoma,  73190,  United States
Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001,  United States
Texas
      U.S. Oncology, Houston,  Texas,  77060,  United States

Study chairs or principal investigators

Paul Sabbatini,  Study Chair,  Eli Lilly and Company   

Study ID Numbers:  CDR0000066766; LILLY-H4Z-MC-JWWI; MSKCC-99001
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003669
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08