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
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
PROJECTED ACCRUAL: A total of 24-72 (12-36 per stratum) will be accrued for this study.
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
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