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Recruitment Status : Withdrawn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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|