celecoxib in treating patients with progressive metastatic differentiated thyroid cancer

Conditions: Head and Neck Cancer

Summary: 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.

Eligibility criteria:
disease characteristics: * histologically confirmed thyroid carcinoma, including 1 of the following subtypes: * papillary * follicular * hurthle cell * insular * assessable disease, defined by at least 1 of the following: * metastatic (including neck lymph nodes) measurable disease * at least 20 mm by conventional techniques or at least 10 mm by spiral ct scan * the following are not considered measurable disease: * leptomeningeal disease * ascites * pleural/pericardial effusion * lymphangitis cutis/pulmonis * abdominal masses that are not confirmed and followed by imaging techniques * cystic lesions * tumor lesions within a previously irradiated area * elevated serum thyroglobulin levels indicating the presence of metastatic disease * must have negative thyroglobulin antibodies * must have progressive disease within the past year, defined by at least 1 of the following: * at least 20% increase in serum thyroglobulin levels * at least 20% increase in the sum of the longest diameter of measurable lesions * appearance of at least 1 new lesion * failed or ineligible for standard therapy with iodine i 131 and/or surgery patient characteristics: age * 18 and over performance status * ecog 0-2 life expectancy * at least 1 year hematopoietic * absolute neutrophil count at least 1,000/mm\^3 * platelet count at least 75,000/mm\^3 hepatic * bilirubin no greater than 2.0 mg/dl * ast/alt no greater than 2 times upper limit of normal renal * creatinine no greater than 2.0 mg/dl cardiovascular * no symptomatic congestive heart failure * no unstable angina pectoris * no uncontrolled cardiac arrhythmia gastrointestinal * no prior symptomatic or complicated peptic ulcer disease by endoscopy within the past 6 months, defined by any of the following conditions: * active gastric or duodenal ulcer * gastric or duodenal perforation * upper gastrointestinal bleeding other * not pregnant or nursing * negative pregnancy test * no prior allergic reaction to celecoxib or sulfonamides * no prior urticaria, asthma, or allergic reaction to aspirin or other nonsteroidal anti-inflammatory agents * no ongoing or active infection * no psychiatric illness or social situation that would preclude study compliance * no other uncontrolled concurrent illness that would preclude study participation prior concurrent therapy: biologic therapy * not specified chemotherapy * more than 1 month since prior systemic chemotherapy endocrine therapy * not specified radiotherapy * see disease characteristics * more than 3 months since prior external beam radiotherapy (unless an indicator lesion is outside the radiation field) * more than 6 months since prior iodine i 131 therapy surgery * see disease characteristics * more than 1 month since prior surgery other * more than 2 weeks since prior conventional doses of celecoxib or rofecoxib for osteoarthritis, rheumatoid arthritis, or dysmenorrhea * no concurrent combination antiretroviral therapy for hiv-positive patients * no other concurrent investigational agents * no concurrent chronic (more than 1 week of therapy) fluconazole therapy * concurrent oral or iv bisphosphonates for bony metastases are allowed * concurrent low-dose aspirin (no greater than 325 mg/day) for cardiovascular disease is allowed

Keywords: insular thyroid cancer recurrent thyroid cancer stage ii follicular thyroid cancer stage ii papillary thyroid cancer stage iv follicular thyroid cancer stage iv papillary thyroid cancer