Phase II Study of Two Dose Levels of Toremifene in the Treatment of Chemotherapy-Resistant Papillary Carcinoma of the Ovary
- 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.
Allocation: Randomized, Primary Purpose: Treatment
James D. Ahlgren, MD
George Washington University
United States: Federal Government
|George Washington University Cancer Center||Washington, District of Columbia 20037|