Sorafenib Tosylate in Treating Patients With Metastatic, Locally Advanced, or Recurrent Medullary Thyroid Cancer
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|ClinicalTrials.gov Identifier: NCT00390325|
Recruitment Status : Active, not recruiting
First Posted : October 19, 2006
Results First Posted : December 21, 2018
Last Update Posted : January 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hereditary Thyroid Gland Medullary Carcinoma Multiple Endocrine Neoplasia Type 2A Multiple Endocrine Neoplasia Type 2B Recurrent Thyroid Gland Carcinoma Stage III Thyroid Gland Medullary Carcinoma AJCC v7 Stage IV Thyroid Gland Medullary Carcinoma AJCC v7 Stage IVA Thyroid Gland Medullary Carcinoma AJCC v7 Stage IVB Thyroid Gland Medullary Carcinoma AJCC v7 Stage IVC Thyroid Gland Medullary Carcinoma AJCC v7||Other: Laboratory Biomarker Analysis Other: Pharmacological Study Drug: Sorafenib Tosylate||Phase 2|
I. To assess objective response rate of sorafenib (BAY 43-9006) (sorafenib tosylate) in metastatic medullary thyroid carcinoma in setting of inherited tumor syndromes, such as multiple endocrine neoplasia (MEN) 2A, MEN 2B, or familial medullary thyroid carcinoma (FMTC).
II. To assess objective response rate of sorafenib (BAY 43-9006) in sporadic metastatic medullary thyroid carcinoma.
I. To assess toxicity of sorafenib (BAY 43-9006) in patients with metastatic medullary thyroid carcinoma.
II. Measure serum tumor markers calcitonin and carcinoembryonic antigen (CEA) pre-, during, and post-treatment to correlate with disease response.
II. Correlate nuclear medicine functional imaging (fludeoxyglucose F 18 positron emission tomography [PET] scan) data obtained at pre-, during, and post-treatment with tumor response in these patients.
III. Correlate dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) data obtained at pre-, during, and post-treatment with changes in tumor permeability and vascularity with tumor response.
IV. Perform pharmacogenomic studies on procured peripheral blood mononuclear cells (PBMCs) if clinical responses are observed in these patients.
V. To correlate between the degree of retrovirus-associated deoxyribonucleic acid (DNA) sequences (Ras)-mitogen-activated protein kinase (MAPK) signaling inhibition with vascular endothelial growth factor (VEGF) expression in the tumor and clinical response.
VI. To correlate between the presence and type of ret proto-oncogene (RET) gene defects in tumor and clinical response.
Patients receive sorafenib tosylate orally (PO) twice daily (BID) on days 1-56. Treatment repeats every 8 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 4 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Sorafenib (BAY 43-9006) in Patients With Metastatic Medullary Thyroid Carcinoma|
|Actual Study Start Date :||October 5, 2006|
|Actual Primary Completion Date :||January 30, 2017|
Experimental: Treatment (sorafenib tosylate)
Patients receive sorafenib tosylate PO BID on days 1-56. Treatment repeats every 8 weeks in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Drug: Sorafenib Tosylate
- Objective Response Rate of Sorafenib Tosylate in Metastatic Medullary Thyroid Carcinoma in Setting of Inherited Tumor Syndromes as Well as in Setting of Sporadic Medullary Thyroid Cancer [ Time Frame: Up to 4 weeks after last dose of sorafenib tosylate ]Measured using MRI scans. Determined using Response Evaluation Criteria in Solid Tumors/World Health Organization response criteria. 95% confidence interval will be calculated to estimate the frequency of response.
- Number of Patients With Decreased Calcitonin Levels [ Time Frame: Up to 4 weeks after last dose of sorafenib tosylate ]Identifying the number of patients with decreased calcitonin levels
- Patient With Decreased Carcinoembryonic Antigen (CEA) Levels [ Time Frame: Up to 4 weeks after last dose of sorafenib tosylate ]Identify the number of patients with decreased Carcinoembryonic Antigen (CEA) levels
- Percent of Baseline Dynamic-Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) Exchange Rate Constant (Kep) [ Time Frame: Up to 4 weeks after last dose of sorafenib tosylate ]Median decrease in exchange rate Kep in index lesions
- Degree of Ras-MAPK Signaling Inhibition in the Tumor [ Time Frame: Up to 4 weeks after last dose of sorafenib tosylate ]Identify the number of patients with degree of Ras-MAPK signaling inhibition
- Degree of Vascular Endothelial Growth Factor (VEGF) Expression in the Tumor [ Time Frame: Up to 4 weeks after last dose of sorafenib tosylate ]Correlated with clinical response.
- Standardized Uptake Value (SUV Max) as Measured by Fludeoxyglucose F-18 Positron Emission Tomography (PET) [ Time Frame: Up to 4 weeks after last dose of sorafenib tosylate ]Identify the median SUV at baseline and 8 week follow up as measured by Fludeoxyglucose F-18 Positron Emission Tomography (PET).
- Number of Patients With Toxicity, Graded Using the Revised National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 [ Time Frame: Up to 4 weeks after last dose of sorafenib tosylate ]Toxicities were graded for patients using the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
- Number of Participants With Ret Proto-Oncogene (RET) Gene Defects in the Tumor [ Time Frame: Baseline ]Percent of patients with RET mutations
- Selected Polymorphisms of Genes Influencing Sorafenib Tosylate Metabolism and/or Resistance Genes That May Predict Response or Toxicity [ Time Frame: Baseline ]Changes will be correlated with toxicity and clinical response to therapy.
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): NCT00390325
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Bhavana Konda||Ohio State University Comprehensive Cancer Center|