Celecoxib in Treating Patients With Progressive Metastatic Differentiated Thyroid Cancer

NCT00061906 | Completed Phase 2 DMC

• 1 other identifier: OSU-0239
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Head and Neck Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  up to 12 months following treatment

Secondary Outcomes (3)

• 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-

  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.

Interventions

celecoxib DRUG

Treatment will be administered on an outpatient basis. Oral celecoxib will be given at the dose of 400 mg BID for total of 12 months. Patients will be advised to take this medication with food to improve absorption.

Also known as: Celebrex, Cobix, Celcoxx, Celexib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (2)

Ohio State University Comrehensive Cancer Center

Columbus, Ohio, 43210-1240, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Related Publications (1)

• Mrozek 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 RESULT

Related Links

• Jamesline

MeSH Terms

Conditions

Head and Neck Neoplasms; Thyroid Neoplasms; Adenocarcinoma, Follicular; Thyroid Cancer, Papillary

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Endocrine System Diseases; Thyroid Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Adenocarcinoma, Papillary

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Manisha H. Shah, MD

  Ohio State University Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2003
• First Posted: June 6, 2003
• Study Start: January 1, 2003
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: February 11, 2014

Record last verified: 2014-02

Locations

US (2)