Sunitinib Malate in Treating Patients With Iodine-Refractory Recurrent or Metastatic Thyroid Cancer
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
Drug: sunitinib malate
Other: laboratory biomarker analysis
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Sunitinib in Iodine Refractory Differentiated Thyroid Cancer and Metastatic Medullary Carcinoma of Thyroid With Functional Imaging Correlation|
- Overall response rate [ Time Frame: At baseline and every 3 months while on study treatment ]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.
- Early PET changes [ Time Frame: Day 7 ]
- Safety and toxicity of sunitinib malate given as a continuous treatment rated for toxicity using the NCI Common Toxicity Criteria (CTC) version 3.0 [ Time Frame: On day 1, monthly while on study treatment, and after completion of study treatment ]
- Overall survival [ Time Frame: At 30 days from the last dose of study treatment and then for 2 years ]
- Duration of response measured from the date of the first objective assessment of partial response (PR) or complete response (CR) to the first date of disease relapse or death from any cause [ Time Frame: At 30 days from last dose of study treatment and then for 2 years ]
- Time-to-tumor progression measured from the date of enrollment to the first date of progression of disease [ Time Frame: At 30 days from the last dose of study treatment and then for 2 years ]
- Serial markers thyroglobulin (WDTC) or calcitonin (MTC) during therapy [ Time Frame: At baseline, day 7, month 3, and then every 3 months during study treatment ]
- Correlation of changes in serial tumor markers with radiologic response [ Time Frame: At baseline, day 7, month 3, and then every 3 months during study treatment ]
|Study Start Date:||July 2007|
|Study Completion Date:||September 2015|
|Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (enzyme inhibitor therapy, antiangiogenesis therapy)
Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.
Drug: sunitinib malate
Other Names:Other: laboratory biomarker analysis
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 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519896
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Renato Martins||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|