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

Inclusion 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

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

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