Celecoxib in Treating Patients With Progressive Metastatic Differentiated Thyroid Cancer

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University Comprehensive Cancer Center
• Treatments: Celecoxib

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