Celecoxib in Treating Patients With Progressive Metastatic Differentiated Thyroid Cancer

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