Toremifene in Treating Patients With Desmoid Tumors

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002595
First received: November 1, 1999
Last updated: July 9, 2013
Last verified: August 2010

November 1, 1999
July 9, 2013
July 1991
May 2003   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00002595 on ClinicalTrials.gov Archive Site
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Toremifene in Treating Patients With Desmoid Tumors
PHASE II STUDY OF THE SAFETY AND EFFICACY OF TOREMIFENE IN THE THERAPY OF DESMOID TUMORS

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Desmoid Tumor
  • Drug: toremifene
  • Procedure: conventional surgery
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
September 2010
May 2003   (final data collection date for primary outcome measure)

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

Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002595
LGH-1011, CDR0000063797, NCI-V91-0211
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Lutheran General Hospital
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Study Chair: Brian L. Samuels, MD Lutheran General Hospital
National Cancer Institute (NCI)
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP