title: Phase II study of celecoxib in metastatic differentiated thyroid carcinoma.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  Ambulatory patients were from tertiary referral academic medical centers.
  
  
  METHODS
  Patients in the study had progressive metastatic DTC and had failed prior standard therapy.
  
  
  METHODS
  Patients were treated with celecoxib 400 mg orally twice a day for 12 months.
  
  
  METHODS
  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.
authors.affiliation: Division of Hematology, Departments of Internal Medicine, The Ohio State University Thyroid Cancer Unit, The Ohio State University Medical Center, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, Columbus, Ohio 43210, USA.
authors.forename: Ewa
authors.initials: E
authors.lastname: Mrozek
authors.forename: Richard T
authors.initials: RT
authors.lastname: Kloos
authors.forename: Matthew D
authors.initials: MD
authors.lastname: Ringel
authors.forename: Laura
authors.initials: L
authors.lastname: Kresty
authors.forename: Paulette
authors.initials: P
authors.lastname: Snider
authors.forename: Daria
authors.initials: D
authors.lastname: Arbogast
authors.forename: Merrill
authors.initials: M
authors.lastname: Kies
authors.forename: Reginald
authors.initials: R
authors.lastname: Munden
authors.forename: Naifa
authors.initials: N
authors.lastname: Busaidy
authors.forename: Mary Jean
authors.initials: MJ
authors.lastname: Klein
authors.forename: Steven I
authors.initials: SI
authors.lastname: Sherman
authors.forename: Manisha H
authors.initials: MH
authors.lastname: Shah
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000068579:Celecoxib; D051546:Cyclooxygenase 2 / Q000032:analysis; D052246:Cyclooxygenase 2 Inhibitors / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011720:Pyrazoles / Q000009:adverse effects / Q000627:therapeutic use*; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D013964:Thyroid Neoplasms / Q000188:drug therapy* / Q000201:enzymology
chemical_list: D052246:Cyclooxygenase 2 Inhibitors; D011720:Pyrazoles; D013449:Sulfonamides; D051546:Cyclooxygenase 2; D000068579:Celecoxib