Recurrent Thyroid Cancer Clinical Trial
Official title:
Phase II Study of Sunitinib in Iodine Refractory Differentiated Thyroid Cancer and Metastatic Medullary Carcinoma of Thyroid With Functional Imaging Correlation
This phase II trial studies how well giving sunitinib malate works in treating patients with iodine-refractory recurrent or metastatic thyroid cancer. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor
PRIMARY OBJECTIVES:
I. Evaluate the response of sunitinib (sunitinib malate) per Response Evaluation Criteria in
Solid Tumors (RECIST) criteria in patients with recurrent/metastatic iodine refractory well
differentiated thyroid carcinoma (WDTC) or medullary thyroid carcinoma (MTC).
SECONDARY OBJECTIVES:
I. Evaluate early positron emission tomography (PET) changes in patients with WDTC and MTC
treated with sunitinib.
II. Determine the safety and toxicity of sunitinib given as a continuous treatment in
patients with WDTC and MTC.
III. Evaluate the effect of sunitinib therapy on overall survival, duration of response and
time-to-progression.
IV. Evaluate serial tumor markers, thyroglobulin (WDTC) or calcitonin (MTC), during therapy.
These measurements will not be used to define disease progression or response.
V. Correlate changes in serial tumor markers with radiologic response.
OUTLINE:
Patients receive sunitinib malate orally (PO) once daily (QD). Treatment continues in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then for 2
years.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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