Celecoxib in Treating Patients With 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.

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