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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
Sponsor:
Information provided by (Responsible Party):
Manisha Shah, Ohio State University Comprehensive Cancer Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: celecoxib Phase 2

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.


Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Drug: celecoxib
    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.
    Other Names:
    • Celebrex
    • Cobix
    • Celcoxx
    • Celexib

Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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.
  3. Evaluate cyclooxygenase (COX)-2 protein expression by immunohistochemistry in tumor biopsies to correlate with clinical response.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
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Study Chair: Manisha H. Shah, MD Ohio State University Comprehensive Cancer Center
More Information
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Additional Information:
Jamesline  This link exits the ClinicalTrials.gov site

Publications of Results:

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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:
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Head and Neck Neoplasms
Thyroid Diseases
Neoplasms by Site
Neoplasms
Endocrine System Diseases
Celecoxib
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
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action