Anaplastic Thyroid Cancer Clinical Trial
Official title:
Phase II Study of BAY 43-9006 in Patients With Metastatic Thyroid Carcinoma
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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