NCT00095693

Sorafenib Tosylate in Treating Patients With Locally Advanced, Metastatic, or Locally Recurrent Thyroid Cancer

Phase II Study of BAY 43-9006 in Patients With Metastatic Thyroid Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II trial to study the effectiveness of sorafenib tosylate in treating patients who have locally advanced, metastatic, or locally recurrent thyroid cancer. Sorafenib tosylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor.

Detailed description

PRIMARY OBJECTIVES: I. Determine objective response rate in patients with locally advanced, metastatic, or locally recurrent differentiated thyroid cancer treated with sorafenib (BAY 43-9006). SECONDARY OBJECTIVES: I. Determine the toxicity of this drug in these patients. II. Correlate thyroglobulin levels with tumor response in patients treated with this drug. III. Correlate fludeoxyglucose F 18 positron emission tomography results with tumor response in patients treated with this drug. IV. Correlate tumor permeability and vascularity, as determined by dynamic contrast-enhanced MRI, with tumor response in patients treated with this drug. V. Determine the pharmacodynamics of this drug in these patients. VI. Correlate the presence and type of B-raf, N-ras, or RET/PTC gene mutations with clinical response in patients treated with this drug. VII. Correlate the degree of Ras-MAPK signaling inhibition and vascular endothelial growth factor expression with clinical response in patients treated with this drug. OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (papillary thyroid cancer that is chemo-naïve vs all others). Patients receive oral sorafenib tosylate twice daily for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients achieving complete remission (CR) receive 8 additional weeks of therapy beyond CR. Patients are followed within 2-4 weeks after completion of study treatment.

Conditions

• Anaplastic Thyroid Cancer
• Insular Thyroid Cancer
• Recurrent Thyroid Cancer
• Stage III Follicular Thyroid Cancer
• Stage III Papillary Thyroid Cancer
• Stage IV Follicular Thyroid Cancer
• Stage IV Papillary Thyroid Cancer

Interventions

Type	Name	Description
DRUG	sorafenib tosylate	Given PO
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	pharmacological study	Correlative studies
RADIATION	fludeoxyglucose F 18	Correlative studies
PROCEDURE	positron emission tomography	Correlative studies
PROCEDURE	dynamic contrast-enhanced magnetic resonance imaging	Correlative studies

Timeline

• Start date: 2004-10-01
• Primary completion: 2005-08-01
• Completion: 2011-12-01
• First posted: 2004-11-08
• Last updated: 2014-01-16

Locations

1 site across 1 country: United States