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Celecoxib in Treating Patients With Progressive Metastatic Differentiated Thyroid Cancer

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
celecoxib
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ohio State University Comrehensive Cancer Center
  • University of Texas - MD Anderson Cancer Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
June 5, 2003
Last Updated
February 10, 2014
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00061906
Brief Title
Celecoxib in Treating Patients With Progressive Metastatic Differentiated Thyroid Cancer
Official Title
Phase II Study Of Celecoxib In Metastatic Differentiated Thyroid Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
celecoxib
Other Intervention Name(s)
Celebrex, Cobix, Celcoxx, Celexib
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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.
Title
Evaluate cyclooxygenase (COX)-2 protein expression by immunohistochemistry in tumor biopsies to correlate with clinical response.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manisha H. Shah, MD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Ohio State University Comrehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16522694
Citation
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.
Results Reference
result
Links:
URL
http://cancer.osu.edu
Description
Jamesline

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Celecoxib in Treating Patients With Progressive Metastatic Differentiated Thyroid Cancer

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