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Celecoxib in Treating Patients With Progressive Metastatic Differentiated Thyroid Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 5, 2003
First Posted Date  ICMJE June 6, 2003
Last Update Posted Date February 11, 2014
Study Start Date  ICMJE January 2003
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2012)
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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2012)
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Celecoxib in Treating Patients With Progressive Metastatic Differentiated Thyroid Cancer
Official Title  ICMJE Phase II Study Of Celecoxib In Metastatic Differentiated Thyroid Carcinoma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE 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
Study Arms  ICMJE Not Provided
Publications * 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. Epub 2006 Mar 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 22, 2012)
25
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2006
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00061906
Other Study ID Numbers  ICMJE OSU-0239
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Manisha Shah, Ohio State University Comprehensive Cancer Center
Study Sponsor  ICMJE Ohio State University Comprehensive Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Manisha H. Shah, MD Ohio State University Comprehensive Cancer Center
PRS Account Ohio State University Comprehensive Cancer Center
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP