Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor
RATIONALE: Sulindac may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Hormone therapy using tamoxifen may fight cancer by blocking the use of estrogen. Combining sulindac with tamoxifen may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving sulindac together with tamoxifen works in treating patients with desmoid tumor.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Sulindac and Tamoxifen in Patients With Desmoid Tumors That Are Recurrent or Not Amenable to Standard Therapy|
- Event-free survival [ Designated as safety issue: No ]
- Tumor response rate [ Designated as safety issue: No ]
- Changes in MRI signal features of tumor with clinical outcomes [ Designated as safety issue: No ]
|Study Start Date:||February 2004|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
- Determine the progression-free survival of patients with desmoid tumor that is recurrent or not amenable to standard therapy treated with sulindac and tamoxifen.
- Determine the safety and efficacy of this regimen, in terms of event-free survival, of these patients.
- Determine the tumor response rate in patients treated with this regimen.
- Correlate changes in MRI signal features of the tumor with clinical outcome in patients treated with this regimen.
- Correlate pathological studies of cyclooxygenase-2 (COX-2) and estrogen/progesterone receptor expression in the tumor with clinical outcome in patients treated with this regimen.
- Collect information about clinical factors that make a tumor unresectable at diagnosis and resectable during the four courses of study treatment.
- Determine whether short-term endocrine toxicity is associated with treatment with this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral sulindac and oral tamoxifen twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
After completion of study treatment, patients are followed for 5 years.
PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study within 4.8 years.
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|Study Chair:||Steve Skapek, MD||University of Chicago Comer Children's Hospital|
|Investigator:||R. Beverly Raney, MD||Driscoll Children's Hospital|