Celecoxib in Treating Patients With Progressive Metastatic Differentiated Thyroid Cancer
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.
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