Ovarian Cancer
Conditions
Keywords
recurrent ovarian epithelial cancer, ovarian serous cystadenocarcinoma
Brief summary
RATIONALE: Estrogen can stimulate the growth of ovarian cancer cells. Hormone therapy using toremifene may fight ovarian cancer by reducing the production of estrogen. PURPOSE: Randomized phase II trial to study the effectiveness of toremifene in treating patients who have recurrent or refractory ovarian cancer.
Detailed description
OBJECTIVES: * Determine the effects of toremifene in terms of response rate, duration of response, duration of survival, and toxicity in patients with chemotherapy resistant papillary carcinoma of the ovary. * Assess whether a dose response effect is likely for this regimen in these patients. * Assess quality of life of these patients. OUTLINE: This is a randomized study. Patients receive one of two doses of oral toremifene daily for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before therapy and then every 4 weeks during therapy. Patients are followed every 12 weeks until death. PROJECTED ACCRUAL: The study was closed before any patient accrual.
Interventions
DRUGtoremifene
Sponsors
George Washington University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
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
Countries
United States
Outcome results
None listed