Recurrent Thyroid Gland Carcinoma Clinical Trial
Official title:
Phase II Study of Cabozantinib in Patients With Radioiodine-Refractory Differentiated Thyroid Cancer Who Progressed on Prior VEGFR-Targeted Therapy
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.
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.
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