RATIONALE: Estrogen can stimulate the growth of ovarian cancer cells. Hormone therapy using LY353381 hydrochloride may fight ovarian or peritoneal 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 metastatic refractory ovarian cancer or primary peritoneal cancer.

Condition	Treatment or Intervention	Phase
recurrent ovarian epithelial cancer peritoneal cavity cancer stage IV ovarian epithelial cancer	Drug: LY353381 hydrochloride	Phase II

Further Study Details: 

OBJECTIVES: I. Evaluate response rate to LY353381 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.

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 metastatic refractory ovarian epithelial cancer OR primary peritoneal cancer provided the clinical and pathological features of the tumor are similar to primary ovarian epithelial carcinoma
• Patients must have received prior chemotherapy including at least one platinum analogue and one taxane analogue unless patient is poor candidate for these treatments due to neuropathy, nephropathy, or hypersensitivity (to Taxol only)
• Bidimensionally measurable disease by x-ray, CT scan, MRI, or physical exam; Ascites not considered measurable or evaluable
• Hormone receptor status: Estrogen receptor status must be known or tissue must be available for analysis

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: See Disease Characteristics; No more than 2 prior chemotherapy regimens (including repeated drug combinations) for patients with potentially platinum-sensitive disease; No more than 3 prior chemotherapy regimens (including repeated drug combinations) for patients with platinum resistant disease; At least 6 weeks since mitomycin or nitrosoureas; At least 3 weeks since other prior chemotherapy Recovered from prior chemotherapy
• Endocrine therapy: At least 3 weeks since hormone replacement therapy; No prior hormonal therapy for ovarian cancer
• Radiotherapy: At least 2 weeks since prior radiotherapy and recovered
• Surgery: Not specified

--Patient Characteristics--

• Age: 18 and over
• Performance status: Karnofsky 70-100%
• Sex: Female
• Menopausal status: Not specified
• Life expectancy: At least 24 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 malignancy within the past 5 years except adequately treated nonmelanomatous cancer of the skin or carcinoma in situ of the cervix

Missouri
      Ellis Fischel Cancer Center - Columbia, Columbia,  Missouri,  65203,  United States
North Carolina
      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States
Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001,  United States
Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030,  United States

Study chairs or principal investigators

Andrzej Piotr Kudelka,  Study Chair,  Eli Lilly and Company   

Study ID Numbers:  CDR0000066767; LILLY-H4Z-MC-JWWJ; MDA-DM-98225
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003670
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08