Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
M.D. Anderson Cancer Center
With
PRIMARY OBJECTIVES: I. To estimate best overall response rate in patients with measurable disease determined by computed tomography (CT) or magnetic resonance imaging (MRI). SECONDARY OBJECTIVES: I. To estimate progression-free survival at 1-year. II. To correlate blood pressure control and change/discontinuation of antihypertensive medications with tumor responses. III. To correlate symptomatology evaluation by the MD Anderson Symptom Inventory (MDASI) with tumor responses. IV. To correlate plasma metanephrines and chromogranin A with tumor responses. V. To correlate plasma C-reactive protein and interleukin-6 with symptoms and tumor responses. VI. Toxicity assessment by the Common Terminology Criteria for Adverse Events (CTCAE). VII. To correlate both c-MET expression by immunohistochemistry (IHC) as well as MET amplification by fluorescence in situ hybridization (FISH) in archived samples and correlate these biomarkers with overall prognosis and responsiveness to cabozantinib (cabozantinib s-malate). EXPLORATORY OBJECTIVES: I. Best overall response rate in patients with bone metastases only (8 patients) as determined by fludeoxyglucose F 18 positron emission tomography/computed tomography (FDG-PET/CT). II. FDG-PET/CT maximum standard uptake value (SUVmax), advanced volumetric measures including peak standard uptake value (SUVpeak), metabolic tumor volume (MTV), and total lesion glycolysis (TLG). III. Time to skeletal related events. IV. Incidence of skeletal related events at 4 months and one year. V. Markers of bone turnover (bone specific alkaline phosphatase and C-terminal telopeptide \[CTx\]). OUTLINE: Patients receive cabozantinib s-malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 4 weeks through week 24 and then every 8 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30-37 days.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
