NCT00519896

Sunitinib Malate in Treating Patients With Iodine-Refractory Recurrent or Metastatic Thyroid Cancer

Phase II Study of Sunitinib in Iodine Refractory Differentiated Thyroid Cancer and Metastatic Medullary Carcinoma of Thyroid With Functional Imaging Correlation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Recurrent Thyroid Cancer
• Stage IVA Follicular Thyroid Cancer
• Stage IVA Papillary Thyroid Cancer
• Stage IVB Follicular Thyroid Cancer
• Stage IVB Papillary Thyroid Cancer
• Stage IVC Follicular Thyroid Cancer
• Stage IVC Papillary Thyroid Cancer
• Thyroid Gland Medullary Carcinoma

Interventions

Type	Name	Description
DRUG	sunitinib malate	Given PO

Timeline

• Start date: 2007-07-01
• Primary completion: 2015-05-01
• Completion: 2015-09-01
• First posted: 2007-08-23
• Last updated: 2017-04-25
• Results posted: 2017-04-25

Locations

1 site across 1 country: United States