renal cell carcinoma
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Histologically confirmed metastatic RCC with a component of clear cell histology. Presence of measurable disease; that is, at least 1 metastatic tumor mass that can be accurately measured in at least 1 dimension over 10 mm with conventional radiological modalities, such as computed tomography and magnetic resonance imaging. Age of over 20 years. ECOG performance status of 0 or 1. Life expectancy of over 12 weeks
Exclusion criteria
Exclusion criteria: Prior use of sunitinib Seizure disorder, evidence of brain metastases, spinal cord compression or carcinomatous meningitis. Active bacterial, fungal or viral infection. History of malignancy other than RCC except for those treated with curative intent with no evidence of disease for at least 2 years. Other severe acute or chronic medical condition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Before and during treatment with sunitinib, measure serum levels of several molecules (E-cadherin, N-cadherin, fibronectin, MMP-2, MMP-3, MMP-9, MT-MMP-1, TIMP-1, TIMP-2, clusterin, bFGF, uPA and uPAR), which have been shown to be regulated by activated p44/42 MAPK and Akt and to be involved in the acquisition of an EMT phenotype in our preliminary experiments, in patients with metastatic RCC by sandwich enzyme-linked immunosorbent assay (ELISA) kits. | — |
Countries
Japan