Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor
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|ClinicalTrials.gov Identifier: NCT00068419|
Recruitment Status : Completed
First Posted : September 11, 2003
Results First Posted : December 4, 2013
Last Update Posted : February 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Desmoid Tumor||Drug: tamoxifen citrate Drug: sulindac Other: laboratory biomarker analysis||Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Sulindac and Tamoxifen in Patients With Desmoid Tumors That Are Recurrent or Not Amenable to Standard Therapy|
|Study Start Date :||February 2004|
|Actual Primary Completion Date :||April 26, 2010|
|Actual Study Completion Date :||April 26, 2010|
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: laboratory biomarker analysis
- Percentage of Patients Failure Free at 2 Years Following Study Entry [ Time Frame: Up to 2 years ]Kaplan Meier estimate of failure free survival at 2 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
- Percentage of Patients Experiencing a Grade 3 or Higher Adverse Event During Therapy. [ Time Frame: Up to 12 months ]The percentage of patients experiencing a grade 3 or higher adverse event as assessed by the National Cancer Institute Common Toxicity Terminology for Adverse Events v3.0
- Percentage of Patients With Tumor Response From Imaging [ Time Frame: Baseline up to 5 years ]Percentage of patients with a tumor response where tumor response is assessed according to Response Evaluation Criteria in Solid Tumors (RECIST)
- Mean Change in Response Measured by MRI [ Time Frame: From baseline to up to 5 years ]The mean change in response measured by MRI. Response is assessed by the lesion size which is derived from the sum of the longest of the three orthogonal diameters (from MRI) of each target lesion.
- Percentage of Patients Failure Free at 2 Years by Pathological Response [ Time Frame: From enrollment to up to 2 years ]The failure free survival is compared by the log-rank test between patient subgroups defined by pathological response of cyclooxygenase-2 (COX-2) and estrogen/progesterone receptor expression
- Percentage of Patients Experiencing Short-term Endocrine Toxicity [ Time Frame: At study entry ]The percentage of patients experiencing short-term endocrine toxicity between treatment groups is compared using the chi-square test
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00068419
|United States, California|
|Children's Oncology Group|
|Monrovia, California, United States, 91016|
|Principal Investigator:||Stephen Skapek, MD||Children's Oncology Group|