Toremifene in Treating Patients With Ovarian Cancer
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Study of Two Dose Levels of Toremifene in the Treatment of Chemotherapy-Resistant Papillary Carcinoma of the Ovary|
|Actual Study Start Date:||July 22, 1999|
|Study Completion Date:||February 22, 2017|
|Primary Completion Date:||February 22, 2017 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003865
|United States, District of Columbia|
|George Washington University Cancer Center|
|Washington, D.C., District of Columbia, United States, 20037|
|Study Chair:||James D. Ahlgren, MD||George Washington University|