Toremifene in Treating Patients With Desmoid Tumors
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|ClinicalTrials.gov Identifier: NCT00002595|
Recruitment Status : Completed
First Posted : April 22, 2004
Last Update Posted : July 10, 2013
RATIONALE: Estrogen can stimulate the growth of cancer cells. Hormone therapy using toremifene may fight the growth of desmoid tumors by reducing the production of estrogen.
PURPOSE: Phase II trial to study the effectiveness of toremifene in treating patients with desmoid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Desmoid Tumor||Drug: toremifene Procedure: conventional surgery||Phase 2|
OBJECTIVES: I. Determine the efficacy of toremifene in terms of tumor response rate and symptom relief in patients with desmoid tumors. II. Determine the safety of this regimen in these patients. III. Determine the quality of life of patients treated with this regimen.
OUTLINE: Patients are stratified by gender. Patients receive oral toremifene daily until complete or maximal response in the absence of disease progression or unacceptable toxicity. Patients achieving maximal response undergo complete resection of all lesions, if feasible. Nonsurgical candidates with severe or life-threatening disease not achieving partial or complete response or symptom relief at 12 months may continue on toremifene at the discretion of the study chairperson. Patients with stable disease who do not undergo surgery may continue on toremifene for a maximum of 12 months at the discretion of the treating physician. Patients who continue to experience symptom relief at 12 months may continue on toremifene at the discretion of the study chairperson. Quality of life is assessed at baseline and at 2 and 6 months. Patients are followed every 8 weeks for 4 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 24-72 (12-36 per stratum) will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Official Title:||PHASE II STUDY OF THE SAFETY AND EFFICACY OF TOREMIFENE IN THE THERAPY OF DESMOID TUMORS|
|Study Start Date :||July 1991|
|Actual Primary Completion Date :||May 2003|
|Actual Study Completion Date :||September 2010|
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): NCT00002595
|United States, Illinois|
|Lutheran General Hospital|
|Park Ridge, Illinois, United States, 60068|
|Study Chair:||Brian L. Samuels, MD||Advocate Lutheran General Hospital|