Celecoxib in Treating Patients With Progressive Metastatic Differentiated Thyroid Cancer
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ClinicalTrials.gov Identifier: NCT00061906 |
Recruitment Status
:
Completed
First Posted
: June 6, 2003
Last Update Posted
: February 11, 2014
|
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Head and Neck Cancer | Drug: celecoxib | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study Of Celecoxib In Metastatic Differentiated Thyroid Carcinoma |
Study Start Date : | January 2003 |
Actual Primary Completion Date : | June 2006 |
Actual Study Completion Date : | June 2006 |

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Drug: celecoxib
- Celebrex
- Cobix
- Celcoxx
- Celexib
- Examine efficacy of celecoxib in patients with progressive metastatic differentiated thyroid carcinoma by assessing progression free survival. [ Time Frame: up to 12 months following treatment ]
- 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- [ Time Frame: pre-study, every eight weeks and off study ]
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00061906
United States, Ohio | |
Ohio State University Comrehensive Cancer Center | |
Columbus, Ohio, United States, 43210-1240 | |
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Manisha H. Shah, MD | Ohio State University Comprehensive Cancer Center |
Additional Information:
Publications of Results:
Responsible Party: | Manisha Shah, Principal Investigator, Ohio State University Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00061906 History of Changes |
Other Study ID Numbers: |
OSU-0239 |
First Posted: | June 6, 2003 Key Record Dates |
Last Update Posted: | February 11, 2014 |
Last Verified: | February 2014 |
Keywords provided by Manisha Shah, Ohio State University Comprehensive Cancer Center:
insular thyroid cancer recurrent thyroid cancer stage II follicular thyroid cancer |
stage II papillary thyroid cancer stage IV follicular thyroid cancer stage IV papillary thyroid cancer |
Additional relevant MeSH terms:
Thyroid Diseases Head and Neck Neoplasms Thyroid Neoplasms Endocrine System Diseases Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Celecoxib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents |