Clinical trial NCT00061906 (phase 2, status: completed)
Conditions: head and neck cancer
ICD codes: C76.0, C47.0, C49.0, C77.0, D17.0, D21.0, D36.11
Drugs: celecoxib
SMILES: COC1=CC=C(C=C1)C(=O)CC(=O)C1=CC=C(C=C1)C(C)(C)C
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