Toremifene in Treating Patients With Ovarian Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: toremifene


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Toremifene<br>All enrolled patients | Drug: toremifene<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent ovarian epithelial cancer, ovarian serous cystadenocarcinoma