Phase II Study of Sunitinib in Iodine Refractory Differentiated Thyroid Cancer and Metastatic Medullary Carcinoma of Thyroid With Functional Imaging Correlation
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).
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
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.
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
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate
A response rate of 20% would be considered favorable and would justify further study. Responses include both complete and partial responses, as defined by RECIST criteria.
At baseline and every 3 months while on study treatment
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
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