Phase II Study of Two Dose Levels of Toremifene in the Treatment of Chemotherapy-Resistant Papillary Carcinoma of the Ovary

Date de début de l'étude : 22 juillet 1999

DISEASE CHARACTERISTICS: Histologically confirmed serous papillary carcinoma of the ovary Recurrent or refractory disease following at least one regimen including paclitaxel, cisplatin, or carboplatin Measurable disease outside of irradiated field No CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 16 weeks Hematopoietic: Absolute neutrophil count at least 1,800/mm^3 Platelet count at least 125,000/mm^3 No history of thrombosis or thromboembolic events Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 2 months after study No other concurrent second malignancy or prior malignancy within past 5 years, except basal or squamous cell skin cancer or curatively treated stage I carcinoma of the cervix No concurrent infection At least 3 days since prior fever (unless due to tumor) No other concurrent severe medical illness No HIV positivity PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No concurrent chemotherapy Endocrine therapy: No prior tamoxifen or antiestrogen therapy Radiotherapy: See Disease Characteristics At least 6 months since prior radiotherapy No concurrent radiotherapy except to symptomatic or potentially disabling bone lesion accompanied by other measurable disease Surgery: Not specified Other: No concurrent anticoagulants No other concurrent therapeutic trials