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Celecoxib in Treating Patients With Progressive Metastatic Differentiated Thyroid Cancer
This study is ongoing, but not recruiting participants.
First Received: June 5, 2003   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00061906
  Purpose

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 Intervention Phase
Head and Neck Cancer
Drug: celecoxib
Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer Thyroid Cancer
Drug Information available for: Celecoxib Thyroid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study Of Celecoxib In Metastatic Differentiated Thyroid Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00061906

Locations
United States, Ohio
Arthur G. James Cancer Hospital at Ohio State University
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
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Investigators
Study Chair: Manisha H. Shah, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000302439, OSU-0239, OSU-2003C0003
Study First Received: June 5, 2003
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00061906     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Anti-Inflammatory Agents
Adenocarcinoma, Follicular
Celecoxib
Thyroid Neoplasms
Thyroid Cancer, Papillary
Cyclooxygenase Inhibitors
Endocrine System Diseases
Recurrence
Carcinoma
Analgesics, Non-Narcotic
Thyroid Cancer, Follicular
Head and Neck Neoplasms
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Endocrinopathy
Antirheumatic Agents
Thyroid Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Celecoxib
Thyroid Neoplasms
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Endocrine System Diseases
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Head and Neck Neoplasms
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Thyroid Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009