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: A total of 60 patients will be accrued for this study.

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