Sorafenib Tosylate in Treating Patients With Locally Advanced, Metastatic, or Locally Recurrent Thyroid Cancer
|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||Drug: sorafenib tosylate Other: laboratory biomarker analysis Other: pharmacological study Radiation: fludeoxyglucose F 18 Procedure: positron emission tomography Procedure: dynamic contrast-enhanced magnetic resonance imaging||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Study of BAY 43-9006 in Patients With Metastatic Thyroid Carcinoma|
- Objective response rate [ Time Frame: Up to 4 weeks ]The 95% confidence intervals should be provided.
- Incidence of toxicity [ Time Frame: Up to 4 weeks ]
|Study Start Date:||October 2004|
|Study Completion Date:||December 2011|
|Primary Completion Date:||August 2005 (Final data collection date for primary outcome measure)|
Experimental: Treatment (sorafenib tosylate)
Patients receive oral sorafenib tosylate twice daily for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients achieving CR receive 8 additional weeks of therapy beyond CR.
Drug: sorafenib tosylate
Other Names:Other: laboratory biomarker analysis
Correlative studiesOther: pharmacological study
Other Name: pharmacological studiesRadiation: fludeoxyglucose F 18
Other Names:Procedure: positron emission tomography
Other Names:Procedure: dynamic contrast-enhanced magnetic resonance imaging
Other Name: DCE-MRI
I. Determine objective response rate in patients with locally advanced, metastatic, or locally recurrent differentiated thyroid cancer treated with sorafenib (BAY 43-9006).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00095693
|United States, Ohio|
|Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Manisha Shah||Ohio State University|