Phase II Study of Sunitinib in Iodine Refractory Differentiated Thyroid Cancer and Metastatic Medullary Carcinoma of Thyroid With Functional Imaging Correlation
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.
Interventional
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
No
Renato Martins
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
6494
NCT00519896
July 2007
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |