Hormone Therapy With Arzoxifene Hydrochloride in Treating Women With Recurrent, Advanced, or Metastatic Endometrial Cancer

• Status: Completed
• Trial end date: 2001-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Estrogen can stimulate the growth of endometrial cancer cells. Hormone therapy using arzoxifene hydrochloride may fight the endometrial 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 recurrent, advanced, or metastatic endometrial cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

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