Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor
Drug: tamoxifen citrate
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
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 [ Time Frame: Study enrollment until time of disease progression or death as a first event (maximum follow-up 5 years) ] [ Designated as safety issue: No ]Two-year event-free survival (EFS). Events include disease progression (increase in the greatest product of 2 perpendicular diameters of any lesion by > 25% or new biopsy-proven lesions), and death in absence of disease progression. Reported as Kaplan-Meier estimate of two-year EFS proportion.
- Toxicity as Assessed by the National Cancer Institute Common Toxicity Terminology for Adverse Events v3.0 [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
- Tumor Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Changes in Magnetic Resonance Imaging (MRI) Signal Features [ Time Frame: From baseline to up to 5 years ] [ Designated as safety issue: No ]MRI must include images in at least two planes with (a) pre-contrast images with the following pulse sequences T-1 weighted, fast spin echo T-2 weighted with fat saturation, and a short tau inversion recovery (STIR); and (b) post-contrast images with T-1 weighted pulse sequence with fat suppression.
|Study Start Date:||February 2004|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Experimental: Treatment (enzyme inhibitor therapy, anti-estrogen therapy)
Patients receive oral sulindac and oral tamoxifen citrate 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.
Drug: tamoxifen citrate
Other Names:Drug: sulindac
Other Names:Other: laboratory biomarker analysis
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 these patients.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068419
|United States, California|
|Children's Oncology Group|
|Monrovia, California, United States, 91016|
|Principal Investigator:||Stephen Skapek, MD||Children's Oncology Group|