NCT00061906

Celecoxib in Treating Patients With Progressive Metastatic Differentiated Thyroid Cancer

Phase II Study Of Celecoxib In Metastatic Differentiated Thyroid Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2003-01-01
• Primary completion: 2006-06-01
• Completion: 2006-06-01
• First posted: 2003-06-06
• Last updated: 2014-02-11

Locations

2 sites across 1 country: United States