Head and Neck Cancer Clinical Trial
Official title:
Phase II Study Of Celecoxib In Metastatic Differentiated Thyroid Carcinoma
RATIONALE: Celecoxib may stop the growth of thyroid cancer by stopping blood flow to the
tumor and by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who
have progressive metastatic differentiated thyroid cancer.
OBJECTIVES:
- Determine the efficacy of celecoxib, in terms of progression-free survival, in patients
with progressive metastatic differentiated thyroid carcinoma.
- Correlate cyclooxygenase (COX)-2 protein expression in tumor biopsies by
immunohistochemistry with clinical response in patients treated with this drug.
OUTLINE: Patients receive oral celecoxib twice daily beginning on day 1. Treatment continues
for 1 year in the absence of disease progression or unacceptable toxicity. Patients who
achieve a complete response (CR) receive 3 additional months of therapy beyond documentation
of CR.
Patients are followed at 4-8 weeks.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study within
approximately 6 months.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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