Celecoxib in Treating Patients With Progressive Metastatic Differentiated Thyroid Cancer

The Ohio State University

Status and phase

Completed

Phase 2

Conditions

Head and Neck Cancer

Treatments

Drug: celecoxib

Study type

Interventional

Funder types

Other

Identifiers

NCT00061906

OSU-0239

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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