A Phase II Study of Sulindac and Tamoxifen in Patients With Desmoid Tumors That Are Recurrent or Not Amenable to Standard Therapy
I. Determine the progression-free survival of patients with desmoid tumor that is recurrent
or not amenable to standard therapy treated with sulindac and tamoxifen.
II. Determine the safety and efficacy of this regimen, in terms of event-free survival, of
I. Determine the tumor response rate in patients treated with this regimen. II. Correlate
changes in MRI signal features of the tumor with clinical outcome in patients treated with
III. Correlate pathological studies of cyclooxygenase-2 (COX-2) and estrogen/progesterone
receptor expression in the tumor with clinical outcome in patients treated with this
IV. Collect information about clinical factors that make a tumor unresectable at diagnosis
and resectable during the four courses of study treatment.
V. 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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The method of Woolson will be used and one sample log-rank test will be applied to compare the event free survival on this study to the fixed expected outcome, F0 (t). Monitoring will be accomplished using an O'Brien and Fleming boundary, truncated at 3 standard deviations.
Up to 2 years
Children's Oncology Group
United States: Institutional Review Board
|Children's Oncology Group||Arcadia, California 91006-3776|