Sunitinib Malate in Treating Patients With Thyroid Cancer That Did Not Respond to Iodine I 131 and Cannot Be Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT00381641|
Recruitment Status : Active, not recruiting
First Posted : September 28, 2006
Results First Posted : September 15, 2017
Last Update Posted : December 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Differentiated Thyroid Gland Carcinoma Recurrent Thyroid Gland Carcinoma Refractory Thyroid Gland Carcinoma Stage III Thyroid Gland Follicular Carcinoma AJCC v7 Stage III Thyroid Gland Medullary Carcinoma AJCC v7 Stage IV Thyroid Gland Follicular Carcinoma AJCC v7 Stage IV Thyroid Gland Medullary Carcinoma AJCC v7 Stage IV Thyroid Gland Papillary Carcinoma AJCC v7 Stage IVA Thyroid Gland Follicular Carcinoma AJCC v7 Stage IVA Thyroid Gland Medullary Carcinoma AJCC v7 Stage IVA Thyroid Gland Papillary Carcinoma AJCC v7 Stage IVB Thyroid Gland Follicular Carcinoma AJCC v7 Stage IVB Thyroid Gland Medullary Carcinoma AJCC v7 Stage IVB Thyroid Gland Papillary Carcinoma AJCC v7 Stage IVC Thyroid Gland Follicular Carcinoma AJCC v7 Stage IVC Thyroid Gland Medullary Carcinoma AJCC v7 Stage IVC Thyroid Gland Papillary Carcinoma AJCC v7 Thyroid Gland Hurthle Cell Carcinoma Unresectable Thyroid Gland Carcinoma||Other: Laboratory Biomarker Analysis Other: Pharmacogenomic Study Drug: Sunitinib Drug: Sunitinib Malate||Phase 2|
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. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for up to 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Sunitinib (SU11248) in Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers and Medullary Thyroid Cancers|
|Actual Study Start Date :||August 8, 2006|
|Actual Primary Completion Date :||December 31, 2016|
Experimental: Treatment (sunitinib malate)
Patients receive sunitinib malate PO QD on days 1-28. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
Other: Laboratory Biomarker Analysis
Optional correlative studies
Other: Pharmacogenomic Study
Optional correlative studies
Other Name: PHARMACOGENOMIC
Drug: Sunitinib Malate
- Objective Response Rate, Assessed Using the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 2 years ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or 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."
- 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 ]Any grade toxicity of any type, regardless of attribution
- Overall Survival [ Time Frame: Up to 10 years ]Kaplan-Meier curves will be generated and 95% confidence intervals will be derived for median overall survival.
- Time to Progression or Death Evaluated Using the RECIST [ Time Frame: Time from start of treatment to time of progression or death of any cause, assessed up to 10 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00381641
|Principal Investigator:||Tanguy Y Seiwert||University of Chicago Comprehensive Cancer Center|