Sunitinib in Treating Patients With Thyroid Cancer That Did Not Respond to Iodine I 131 and Cannot Be Removed by Surgery
|Recurrent Thyroid Gland Carcinoma Stage III Thyroid Gland Follicular Carcinoma Stage III Thyroid Gland Medullary Carcinoma Stage IV Thyroid Gland Follicular Carcinoma Stage IV Thyroid Gland Medullary Carcinoma Stage IV Thyroid Gland Papillary Carcinoma Stage IVA Thyroid Gland Follicular Carcinoma Stage IVA Thyroid Gland Medullary Carcinoma Stage IVA Thyroid Gland Papillary Carcinoma Stage IVB Thyroid Gland Follicular Carcinoma Stage IVB Thyroid Gland Medullary Carcinoma Stage IVB Thyroid Gland Papillary Carcinoma Stage IVC Thyroid Gland Follicular Carcinoma Stage IVC Thyroid Gland Medullary Carcinoma Stage IVC Thyroid Gland Papillary Carcinoma Thyroid Gland Oncocytic Follicular Carcinoma||Other: Laboratory Biomarker Analysis Other: Pharmacogenomic Study Drug: Sunitinib Malate||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Sunitinib (SU11248) in Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers and Medullary Thyroid Cancers|
- Objective response rate, assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 2 years ]
- Incidence of toxicity, graded according to the Common Terminology Criteria for Adverse Events version 3.0 [ Time Frame: From time of first treatment with sunitinib, assessed up to 2 years ]
- Overall survival [ Time Frame: Up to 2 years ]Kaplan-Meier curves will be generated and 90% confidence intervals will be derived for median progression-free and overall survival.
- Time to progression evaluated using the RECIST [ Time Frame: Time from start of treatment to time of progression or death of any cause, assessed up to 2 years ]
- Changes in laboratory correlates analyzed using paired t-tests [ Time Frame: Baseline to 2 years ]Relevant laboratory correlates will be compared between responders and non-responders using the Wilcoxon rank sum test. The association between the presence or absence of RET gene rearrangements/mutations and tumor response, as well as the association between germ-line polymorphisms in the RET gene and response, will be analyzed using Fisher's exact test. The correlative and genetic data will also be entered as covariates (univariate analyses only due to the small sample size) in a Cox regression model of progression-free survival.
|Study Start Date:||August 2006|
|Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (sunitinib malate)
Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
Other: Laboratory Biomarker Analysis
Optional correlative studiesOther: Pharmacogenomic Study
Optional correlative studies
Other Name: PHARMACOGENOMICDrug: Sunitinib Malate
I. Determine the response rate of single agent sunitinib (sunitinib malate) in patients with iodine refractory, unresectable well-differentiated thyroid cancer (WDTC) who have evidence of disease progression within 6 months of study enrollment.
II. Determine the response rate of single agent sunitinib in patients with medullary thyroid cancer (MTC) who have evidence of disease progression within 6 months of study enrollment.
III. Determine the toxicity, duration of response, progression free survival, and overall survival in patients with WDTC or MTC treated with single agent sunitinib.
IV. Determine whether the presence of ret proto-oncogene (RET) gene rearrangements in patients with WDTC or RET mutations in patients with MTC predict response to sunitinib.
V. Determine whether therapy with sunitinib affects phosphorylation of downstream RET effector, mitogen-activated protein kinase 1 (ERK), in WDTC and MTC tissue.
VI. Determine whether specific germ-line polymorphisms in the RET gene are associated with favorable outcome in patients with WDTC treated with sunitinib.
OUTLINE: Patients are assigned to 1 of 2 cohorts according to type of thyroid cancer (medullary vs well-differentiated).
Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00381641
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637|
|Decatur Memorial Hospital|
|Decatur, Illinois, United States, 62526|
|NorthShore University HealthSystem-Evanston Hospital|
|Evanston, Illinois, United States, 60201|
|Ingalls Memorial Hospital|
|Harvey, Illinois, United States, 60426|
|Joliet Oncology-Hematology Associates Limited|
|Joliet, Illinois, United States, 60435|
|Loyola University Medical Center|
|Maywood, Illinois, United States, 60153|
|Peoria, Illinois, United States, 61615|
|Central Illinois Hematology Oncology Center|
|Springfield, Illinois, United States, 62702|
|Southern Illinois University School of Medicine|
|Springfield, Illinois, United States, 62702|
|United States, Indiana|
|Fort Wayne Medical Oncology and Hematology Inc-Parkview|
|Fort Wayne, Indiana, United States, 46845|
|Northern Indiana Cancer Research Consortium|
|South Bend, Indiana, United States, 46628|
|United States, Maryland|
|University of Maryland/Greenebaum Cancer Center|
|Baltimore, Maryland, United States, 21201|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Oncology Care Associates PLLC|
|Saint Joseph, Michigan, United States, 49085|
|United States, Missouri|
|Mercy Hospital Saint Louis|
|Saint Louis, Missouri, United States, 63141|
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|United States, Wisconsin|
|Froedtert and the Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Jonas De Souza||University of Chicago Comprehensive Cancer Center|