NCT02237157

A Dose Escalation Safety Study of Locally-Delivered Gemcitabine in Pancreatic Cancer

A Dose Escalation Safety Study of Locally-Delivered (Intra-Arterial) Gemcitabine in Unresectable Adenocarcinoma of the Pancreas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: RenovoRx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine, local delivery	Intra-arterial targeted drug delivery

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2014-09-11
• Last updated: 2021-05-07
• Results posted: 2021-05-07

Locations

2 sites across 1 country: United States