Celecoxib in Treating Patients With Progressive Metastatic Differentiated Thyroid Cancer

NCT ID: NCT00061906

Last Updated: 2014-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2006-06-30

Brief 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.

Detailed 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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

celecoxib

Treatment will be administered on an outpatient basis. Oral celecoxib will be given at the dose of 400 mg BID for total of 12 months. Patients will be advised to take this medication with food to improve absorption.

Intervention Type: DRUG

Other Intervention Names

Celebrex; Cobix; Celcoxx; Celexib

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Manisha Shah

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manisha H. Shah, MD

Role: STUDY_CHAIR

Ohio State University Comprehensive Cancer Center

Locations

Ohio State University Comrehensive Cancer Center

Columbus, Ohio, United States

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

References

Mrozek E, Kloos RT, Ringel MD, Kresty L, Snider P, Arbogast D, Kies M, Munden R, Busaidy N, Klein MJ, Sherman SI, Shah MH. Phase II study of celecoxib in metastatic differentiated thyroid carcinoma. J Clin Endocrinol Metab. 2006 Jun;91(6):2201-4. doi: 10.1210/jc.2005-2498. Epub 2006 Mar 7.

Reference Type: RESULT

PMID: 16522694 (View on PubMed)

Related Links

http://cancer.osu.edu

Jamesline

Other Identifiers

OSU-0239

Identifier Type: -

Identifier Source: org_study_id