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

Inclusion 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

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

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