Celecoxib in Treating Patients With Progressive Metastatic Differentiated Thyroid Cancer

Phase 2

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT00061906
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2003-06-05
• Study First Submitted QC: 2003-06-05
• Study First Posted: 2003-06-06
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-10
• Last Update Posted: 2014-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Examine efficacy of celecoxib in patients with progressive metastatic differentiated thyroid carcinoma by assessing progression free survival.	up to 12 months following treatment

Secondary Outcome Measures

Name	Time	Method
Quantifying gene expression and protein levels of angiogenic markers[vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF), and tumor necrosis factor (TNF)-α] in peripheral blood mononuclear cells (PBMCs) from pre-,during-	pre-study, every eight weeks and off study
Quantifying gene expression and protein levels of cytokines [interleukin (IL)-10, IL-12, IL-6 and interferon (IFN)-γ] in peripheral blood mononuclear cells from pre-,during-, and post-treatment blood samples.
Evaluate cyclooxygenase (COX)-2 protein expression by immunohistochemistry in tumor biopsies to correlate with clinical response.

Trial Locations

Locations (2)

Ohio State University Comrehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States

University of Texas - MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States