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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Treatment will be administered on an outpatient basis. Oral celecoxib will be given at the dose of 400 mg BID for total of 12 months. Patients will be advised to take this medication with food to improve absorption.
Ohio State University Comrehensive Cancer Center
Columbus, Ohio, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Examine efficacy of celecoxib in patients with progressive metastatic differentiated thyroid carcinoma by assessing progression free survival.
Time frame: up to 12 months following treatment
Quantifying gene expression and protein levels of angiogenic markers[vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF), and tumor necrosis factor (TNF)-α] in peripheral blood mononuclear cells (PBMCs) from pre-,during-
Time frame: pre-study, every eight weeks and off study
Quantifying gene expression and protein levels of cytokines [interleukin (IL)-10, IL-12, IL-6 and interferon (IFN)-γ] in peripheral blood mononuclear cells from pre-,during-, and post-treatment blood samples.
Evaluate cyclooxygenase (COX)-2 protein expression by immunohistochemistry in tumor biopsies to correlate with clinical response.
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