Celecoxib |
Celebrex |
Clinical Trial: Celecoxib in Treating Patients With Progressive Metastatic Differentiated Thyroid Cancer
This study is no longer recruiting patients.
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
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
- 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
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
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
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
- Celebrex (Drug Digest)
- Celebrex Consumer Information (U.S. Food and Drug Administration)

Not Signed In -

