Clinical trial NCT00381641
Conditions: 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 Oncocytic Carcinoma Unresectable Thyroid Gland Carcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2006-08-29; Completion date: 2024-12-10
Enrollment: 63 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well sunitinib malate works in treating patients with thyroid cancer that did not respond to iodine I 131 (radioactive iodine) and cannot be removed by surgery. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed description:
PRIMARY OBJECTIVES:

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.

Arms: arm 1: Patients receive sunitinib malate PO QD on days 1-28. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Pharmacogenomic Study intervention 3: Sunitinib intervention 4: Sunitinib Malate
Intervention descriptions: intervention 1: Optional correlative studies intervention 2: Optional correlative studies intervention 3: Given PO intervention 4: Given PO

Protocol documents: