Conditions: Pancreatic Cancer
Keywords: pancreatic cancer unresectable gemcitabine device local delivery chemoembolization
Allocation: NON_RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 20
Healthy volunteers: no

Brief summary:
A dose escalation, safety study of local (intra-arterially) delivered gemcitabine to the pancreas using the RenovoCath R120 catheter to determine the maximum tolerated dose.

Detailed description:
Patients diagnosed with unresectable pancreatic cancer who may or may not have had prior chemotherapy or radiation therapy may be eligible to enroll in this dose escalation study to determine the maximum tolerated dose of gemcitabine to be delivered locally to the pancreatic tumors using the RenovoCath R120 catheter. Patients enrolled may receive up to 8 catheterizations for delivering gemcitabine directly to the pancreatic tumors starting at a reduced dose( 1/4 of standard i.v. gemcitabine dose), then every two doses, increase the dose by 25% if there are no toxicities up to a maximum dose of 1000 mg/m2. There are four cycles, with two doses per cycle. Imaging studies will be conducted as well as assessment for standard, myelosuppresive and gastric toxicities will be assessed. Pain will also be measured throughout the study.

Arms:
arm 1: Gemcitabine; 1 cycle, two doses per cycle; 250mg/m2 dose arm 2: Gemcitabine; 1 cycle, two doses per cycle; 500mg/m2 dose arm 3: Gemcitabine; 1 cycle, two doses per cycle; 750mg/m2 dose arm 4: Gemcitabine; 1 cycle, two doses per cycle; 1000mg/m2 dose

Interventions: intervention 1: Gemcitabine, local delivery
Intervention descriptions: intervention 1: Intra-arterial targeted drug delivery

Protocol document: