Sorafenib Tosylate in Treating Patients With Locally Advanced, Metastatic, or Locally Recurrent Thyroid Cancer
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|ClinicalTrials.gov Identifier: NCT00095693|
Recruitment Status : Terminated
First Posted : November 8, 2004
Last Update Posted : January 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of BAY 43-9006 in Patients With Metastatic Thyroid Carcinoma|
|Study Start Date :||October 2004|
|Actual Primary Completion Date :||August 2005|
|Actual Study Completion Date :||December 2011|
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: laboratory biomarker analysis
Other: pharmacological study
Other Name: pharmacological studies
Radiation: fludeoxyglucose F 18
Procedure: positron emission tomography
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Other Name: DCE-MRI
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00095693
|United States, Ohio|
|Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Manisha Shah||Ohio State University|