Phase I Trial of Gemcitabine With TheraSphere® (Yttrium-90) in Patients With Hepatic Tumors of Pancreatobiliary Origin
Patients with liver predominant cholangiocarcinoma or pancreatic cancer will be considered
for the trial. The patients wre being treated in groups of thre patients. Each three
patients receive a pre-specified dose of gemcitabine with full dose radioembolization using
theraspheres. If no significant side effects are observed then three additional three
patients will be treated with a higher dose of gemcitabine. The purpose to identify the
highest dose of gemcitabine that can be safely combined with theraspheres.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The maximum tolerated dose of gemcitabine when given in combination with therasphere
Patients will receive full dose therasphere. The gemcitabine dose will start out low and the dose will increase after first 3 patients if no significant side effects are observed. The investigators will continue to increase the dose of gemcitabine as long as the investigators do not observe side effects or until we reach full dose of gemcitabine.
Hyun Kevin Kim, MD
Emory University Winship Cancer Institute
United States: Institutional Review Board
|Emory University||Atlanta, Georgia 30322|