NCT00068419

Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor

A Phase II Study of Sulindac and Tamoxifen in Patients With Desmoid Tumors That Are Recurrent or Not Amenable to Standard Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well giving sulindac together with tamoxifen works in treating patients with desmoid tumor. 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.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the safety and efficacy of sulindac and tamoxifen in patients with recurrent desmoid tumor (DT) and primary DT that is not readily amenable to surgery or radiation therapy. SECONDARY OBJECTIVES: I. Determine the tumor response rate in patients treated with this regimen. II. Correlate changes in Magnetic Resonance Imaging (MRI) signal features of the tumor with clinical outcome in patients treated with this regimen. 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 regimen. 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.

Conditions

• Desmoid Tumor

Interventions

Type	Name	Description
DRUG	tamoxifen citrate	Given orally
DRUG	sulindac	Given orally
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2004-02-01
• Primary completion: 2010-04-26
• Completion: 2010-04-26
• First posted: 2003-09-11
• Last updated: 2020-02-19
• Results posted: 2013-12-04

Locations

1 site across 1 country: United States