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||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
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 until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.",
- 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 treatmentthrough study completion, an average of 2 years ]Only adverse events that were grade 3 and higher using NCI Common Toxicity Criteria (CTC) version 3.0 were recorded.
- 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 ]Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
|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
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|