Clinical trial · Interventional
Celecoxib in Treating Patients With Progressive Metastatic Differentiated Thyroid Cancer
Phase II Study Of Celecoxib In Metastatic Differentiated Thyroid Carcinoma
NCT00061906CI-TRIAL-00013713completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| celecoxib | Drug | Celecoxib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Examine efficacy of celecoxib in patients with progressive metastatic differentiated thyroid carcinoma by assessing progression free survival.
- timeFrame
- up to 12 months following treatment
Secondary outcomes (3)
- measure
- Quantifying gene expression and protein levels of angiogenic markers[vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF), and tumor necrosis factor (TNF)-α] in peripheral blood mononuclear cells (PBMCs) from pre-,during-
- timeFrame
- pre-study, every eight weeks and off study
- measure
- Quantifying gene expression and protein levels of cytokines [interleukin (IL)-10, IL-12, IL-6 and interferon (IFN)-γ] in peripheral blood mononuclear cells from pre-,during-, and post-treatment blood samples.
- measure
- Evaluate cyclooxygenase (COX)-2 protein expression by immunohistochemistry in tumor biopsies to correlate with clinical response.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 allowedReferences
Publications (1)
- RESULTMrozek E, Kloos RT, Ringel MD, Kresty L, Snider P, Arbogast D, Kies M, Munden R, Busaidy N, Klein MJ, Sherman SI, Shah MH. Phase II study of celecoxib in metastatic differentiated thyroid carcinoma. J Clin Endocrinol Metab. 2006 Jun;91(6):2201-4. doi: 10.1210/jc.2005-2498. Epub 2006 Mar 7. PMID 16522694