Toremifene in Treating Patients With Desmoid Tumors

Desmoid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002595
• Other study ID #: LGH-1011
• Secondary ID: CDR0000063797NCI
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: July 9, 2013
• Start date: July 1991
• Est. completion date: September 2010

Study information

• Verified date: August 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 2010
• Est. primary completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

DISEASE CHARACTERISTICS: Histologically proven primary or recurrent desmoid tumor Unresectable and symptomatic or progressive disease OR Disease for which a mutilating surgery would be required for complete resection Bidimensionally measurable or clinically evaluable disease

PATIENT CHARACTERISTICS: Age: 16 and over (no prepubertal patients) Performance status:

0-2 Life expectancy: More than 2 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL Transaminases no greater than 3 times upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN Renal: Not specified Cardiovascular: No history of deep vein thrombosis Other: Not pregnant Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No concurrent dexamethasone for antiemesis No other concurrent hormonal therapy, including hormonal contraceptives Radiotherapy: Not specified Surgery: See Disease Characteristics

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Desmoid Tumor

Intervention

Drug:
• toremifene

Procedure:
• conventional surgery

Locations

Country	Name	City	State
United States	Lutheran General Hospital	Park Ridge	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Lutheran General Hospital

Country where clinical trial is conducted

United States,