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Celecoxib in Treating Patients With Progressive Metastatic Differentiated Thyroid Cancer

Information source: Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Head and Neck Cancer

Intervention: celecoxib (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Ohio State University Comprehensive Cancer Center

Official(s) and/or principal investigator(s):
Manisha H. Shah, MD, Study Chair, Affiliation: Ohio State University Comprehensive Cancer Center


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.

Clinical Details

Official title: Phase II Study Of Celecoxib In Metastatic Differentiated Thyroid Carcinoma

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Examine efficacy of celecoxib in patients with progressive metastatic differentiated thyroid carcinoma by assessing progression free survival.

Secondary outcome:

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-

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.

Evaluate cyclooxygenase (COX)-2 protein expression by immunohistochemistry in tumor biopsies to correlate with clinical response.

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.



- 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


- 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


- Cystic lesions

- Tumor lesions within a previously irradiated area

- Elevated serum thyroglobulin levels indicating the presence of metastatic


- Must have negative thyroglobulin antibodies

- Must have progressive disease within the past year, defined by at least 1 of the


- 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


- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 1 year


- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 75,000/mm^3


- Bilirubin no greater than 2. 0 mg/dL

- AST/ALT no greater than 2 times upper limit of normal


- Creatinine no greater than 2. 0 mg/dL


- No symptomatic congestive heart failure

- No unstable angina pectoris

- No uncontrolled cardiac arrhythmia


- 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


- 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


- Not specified


- More than 1 month since prior systemic chemotherapy

Endocrine therapy

- Not specified


- 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


- See Disease Characteristics

- More than 1 month since prior surgery


- 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

Locations and Contacts

Ohio State University Comrehensive Cancer Center, Columbus, Ohio 43210-1240, United States

University of Texas - MD Anderson Cancer Center, Houston, Texas 77030-4009, United States

Additional Information


Starting date: January 2003
Last updated: February 10, 2014

Page last updated: August 20, 2015

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