NCT00003865

Toremifene in Treating Patients With Ovarian Cancer

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: George Washington University · Academic / Other
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	toremifene

Timeline

• Start date: 1999-07-22
• Primary completion: 2017-02-22
• Completion: 2017-02-22
• First posted: 2003-01-27
• Last updated: 2017-07-13

Locations

1 site across 1 country: United States