Phase II study of celecoxib in metastatic differentiated thyroid carcinoma

Ewa Mrozek, Richard T. Kloos, Matthew D. Ringel, Laura Kresty, Paulette Snider, Daria Arbogast, Merrill Kies, Reginald Munden, Naifa Busaidy, Mary Jean Klein, Steven I. Sherman, Manisha H. Shah

Research output: Contribution to journalArticlepeer-review

56 Scopus citations


Context: There is increased cyclooxygenase-2 (COX-2) expression in malignant thyroid nodules compared with nonneoplastic and benign thyroid tissue. Objective: The objective of the study was to evaluate the efficacy of celecoxib, a selective COX-2 inhibitor, in treating patients with progressive metastatic differentiated thyroid cancer (DTC) and to explore the relationship of clinical response to tumor COX-2 expression with immunohistochemistry in a subset of patients. Design: The study was a prospective phase II trial with Fleming single-stage design powered at 80% with a 5% rejection error to detect more than 20% progression-free survival at 12 months. Setting: Ambulatory patients were from tertiary referral academic medical centers. Patients: Patients in the study had progressive metastatic DTC and had failed prior standard therapy. Intervention: Patients were treated with celecoxib 400 mg orally twice a day for 12 months. Main Outcome Measure: The main outcome measure was progression-free survival at 12 months of treatment using Response Evaluation Criteria in Solid Tumors and/or serum thyroglobulin. Results: Twenty-three of 32 patients experienced progressive disease or stopped therapy due to toxicity, thus fulfilling the intent-to-treat study endpoint for celecoxib failure. One patient achieved partial response, and one patient completed 12 months of therapy progression-free. The patient with partial response was on therapy along with seven other patients when the study was terminated. Conclusions: Celecoxib 400 mg orally twice per day fails to halt progressive metastatic DTC in most patients.

Original languageEnglish (US)
Pages (from-to)2201-2204
Number of pages4
JournalJournal of Clinical Endocrinology and Metabolism
Issue number6
StatePublished - 2006

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Biochemistry
  • Endocrinology
  • Clinical Biochemistry
  • Biochemistry, medical


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