NCT00002595

Toremifene in Treating Patients With Desmoid Tumors

PHASE II STUDY OF THE SAFETY AND EFFICACY OF TOREMIFENE IN THE THERAPY OF DESMOID TUMORS

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Advocate Lutheran General Hospital · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Desmoid Tumor

Interventions

Type	Name	Description
DRUG	toremifene
PROCEDURE	conventional surgery

Timeline

• Start date: 1991-07-01
• Primary completion: 2003-05-01
• Completion: 2010-09-01
• First posted: 2004-04-22
• Last updated: 2013-07-10

Locations

1 site across 1 country: United States