Clinical trial NCT01811212
Conditions: Poorly Differentiated Thyroid Gland Carcinoma Recurrent Thyroid Gland Carcinoma Stage I Thyroid Gland Follicular Carcinoma Stage I Thyroid Gland Papillary Carcinoma Stage II Thyroid Gland Follicular Carcinoma Stage II Thyroid Gland Papillary Carcinoma Stage III Thyroid Gland Follicular Carcinoma Stage III Thyroid Gland Papillary Carcinoma Stage IVA Thyroid Gland Follicular Carcinoma Stage IVA Thyroid Gland Papillary Carcinoma Stage IVB Thyroid Gland Follicular Carcinoma Stage IVB Thyroid Gland Papillary Carcinoma Stage IVC Thyroid Gland Follicular Carcinoma Stage IVC Thyroid Gland Papillary Carcinoma Tall Cell Variant Thyroid Gland Papillary Carcinoma Thyroid Gland Oncocytic Follicular Carcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2013-05-08; Completion date: 2017-10-09
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well cabozantinib-s-malate works in treating patients with thyroid cancer that does not respond to treatment. Cabozantinib-s-malate may stop the growth of thyroid cancer by blocking some of the enzymes needed for cell growth. Cabozantinib-s-malate may also stop the growth of thyroid cancer by blocking blood flow to the tumor.

Detailed description:
PRIMARY OBJECTIVES:

I. The objective response rate, defined as the proportion of patients who have had a partial response (PR) or complete response (CR) within the first 6 months after initiation of therapy with cabozantinib (cabozantinib-s-malate).

SECONDARY OBJECTIVES:

I. To assess duration of objective response, progression-free survival and overall survival.

II. To assess tolerability and adverse events of cabozantinib as a 2nd line therapy in patients with differentiated thyroid cancer (DTC).

TERTIARY OBJECTIVES:

I. To assess effect of cabozantinib on serum tumor marker thyroglobulin and its correlation with overall response rate.

II. To assess response of cabozantinib in bone metastasis (bone metastasis-specific progression free survival) as evaluated by pre- and on-study functional imaging such as bone scan, fludeoxyglucose F 18 (18F-FDG) positron emission tomography (PET) scan and/or 18F sodium fluoride (NaF) PET scan.

III. To assess effect of cabozantinib on serum and urinary markers of bone turnover and its correlation with response to bone metastasis.

IV. To assess predictors of response by performing tumor genotype studies (e.g. v-raf murine sarcoma viral oncogene homolog B \[BRAF\], rat sarcoma \[RAS\], phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha \[PIK3CA\], mitogen-activated protein kinase 1 \[MAP2K1\], v-akt murine thymoma viral oncogene homolog 1 \[AKT1\], mesenchymal-epithelial transition \[MET\], rearranged in transformation \[RET\]/papillary thyroid carcinoma \[PTC\] rearrangement) in archived tumor tissue.

V. To assess predictors of response by assessing baseline expression levels of vascular endothelial growth factor (VEGF), phosphorylated vascular endothelial growth factor receptor (pVEGFR), phosphorylated mitogen-activated protein kinase 1 (pERK), phosphorylated AKT1 (pAKT) and/or total met proto-oncogene (MET) by immunohistochemistry in archived tumor tissue.

OUTLINE:

Patients receive cabozantinib-s-malate orally (PO) daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks and then every 3 months for 1 year.

Arms: arm 1: Patients receive cabozantinib-s-malate PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Cabozantinib S-malate intervention 2: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies

Protocol documents: