Patient case: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

Clinical trial: Celecoxib in Treating Patients With Progressive Metastatic Differentiated Thyroid 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.

Detailed description: 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: 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

Relevance to patient case: not relevant