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Phase II Study Of Celecoxib In Metastatic Differentiated Thyroid Carcinoma

Phase 2
18 Years
Not Enrolling
Head and Neck Cancer

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Trial Information

Phase II Study Of Celecoxib In Metastatic Differentiated Thyroid Carcinoma


- 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.

Inclusion Criteria


- 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

- 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

- Cystic lesions

- Tumor lesions within a previously irradiated area

- Elevated serum thyroglobulin levels indicating the presence of metastatic

- Must have negative thyroglobulin antibodies

- Must have progressive disease within the past year, defined by at least 1 of the

- 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



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 1 year


- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 75,000/mm^3


- Bilirubin no greater than 2.0 mg/dL

- AST/ALT no greater than 2 times upper limit of normal


- Creatinine no greater than 2.0 mg/dL


- No symptomatic congestive heart failure

- No unstable angina pectoris

- No uncontrolled cardiac arrhythmia


- 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


- 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


Biologic therapy

- Not specified


- More than 1 month since prior systemic chemotherapy

Endocrine therapy

- Not specified


- 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


- See Disease Characteristics

- More than 1 month since prior surgery


- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Examine efficacy of celecoxib in patients with progressive metastatic differentiated thyroid carcinoma by assessing progression free survival.

Outcome Time Frame:

up to 12 months following treatment

Safety Issue:


Principal Investigator

Manisha H. Shah, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

January 2003

Completion Date:

June 2006

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Thyroid Neoplasms
  • Head and Neck Neoplasms



University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
Ohio State University Comrehensive Cancer Center Columbus, Ohio  43210-1240