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Celecoxib in Treating Patients With Progressive Metastatic Differentiated Thyroid Cancer - Article


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Celecoxib

Celebrex 




Clinical Trial: Celecoxib in Treating Patients With Progressive Metastatic Differentiated Thyroid Cancer

This study is no longer recruiting patients.

Sponsors and Collaborators: Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
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
 Drug: celecoxib
 Procedure: anti-cytokine therapy
 Procedure: antiangiogenesis therapy
 Procedure: biological response modifier therapy
 Procedure: enzyme inhibitor therapy
 Procedure: growth factor antagonist therapy
Phase II

MedlinePlus related topics:  Thyroid Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Celecoxib in Patients With Progressive Metastatic Differentiated Thyroid Carcinoma

Further Study Details: 

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 above,  Genders Eligible for Study:  Both

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


Location Information


Ohio
      Arthur G. James Cancer Hospital at Ohio State University, Columbus,  Ohio,  43210-1240,  United States

Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States

Study chairs or principal investigators

Manisha H. Shah, MD,  Study Chair,  Arthur G. James Cancer Hospital & Richard J. Solove Research Institute   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000302439; OSU-0239; OSU-2003C0003
Record last reviewed:  December 2004
Last Updated:  December 9, 2004
Record first received:  June 5, 2003
ClinicalTrials.gov Identifier:  NCT00061906
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005

Resources



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November 27, 2009



Page Updated: September 6, 2005
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