Toremifene in Treating Patients With Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT00003865|
Recruitment Status : Withdrawn
First Posted : January 27, 2003
Last Update Posted : July 13, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: toremifene||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||February 22, 2017|
|Actual Study Completion Date :||February 22, 2017|
All enrolled patients
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|