Spots Global Cancer Trial Database for Toremifene in Treating Patients With Ovarian Cancer

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Trial Identification

Brief Title: Toremifene in Treating Patients With Ovarian Cancer

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

Study ID: NCT00003865

Conditions

Ovarian Cancer

Interventions

toremifene

Study Description

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.