Selective Transvenous Chemoembolization of Primary Pancreatic Tumors

• Status: Withdrawn
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Catheter directed retrograde venous infusion of gemcitabine/lipiodol into pancreatic tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Treatments: Ethiodized Oil; Gemcitabine

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Pathologically and radiologically-confirmed pancreatic adenocarcinoma confined to the pancreas with initial diagnosis within 8 weeks of consent

• Resectable, borderline-resectable or locally-advanced primary pancreatic adenocarcinoma per NCCN guidelines

• The patient is deemed a candidate for the study by the Johns Hopkins Multidisciplinary Pancreatic Tumor Board

• Preserved liver function (Child-Pugh A-B class) without significant liver decompensation

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at study entry

• Measurable or evaluable disease that will be directly treated with intra-pancreatic therapy (as defined by Response Evaluation Criteria in Solid Tumors [RECIST 1.1]

• Suitable for PRVI, based on blood parameters such as platelet count, LFTs including bilirubin and coagulation status including international normalized ratio (see "Exclusion Criteria" below)

• The patient is able to give informed consent

• The patient, if a woman of childbearing potential, has a negative pregnancy test

• The patient is willing and able to comply with study procedures, scheduled visits, and treatment plans

• Life expectancy of at least 3 months

Exclusion Criteria:

• Serum total bilirubin > 3.0 mg/dL

• Creatinine > 2.0 mg/dL

• Platelets < 75,000/μL

• Hgb < 8.0 g/dl

• ANC ≤ 1,000/μL

• INR > 2.0

• Complete portal vein thrombosis or significant cavernous transformation of the portal vein

• Ascites (trace ascites on imaging is OK)

• The patient is pregnant or breast-feeding

• The patient is allergic to contrast media that cannot be readily managed or prevented with premedication

• Patients with peripheral neuropathy [> grade 1, according to the National Cancer Institute Common Toxicity Criteria v5.0 (CTAE v5.0)]