Pancreatic Adenocarcinoma
Conditions
Keywords
retrograde venous infusion, chemotherapy, gemcitabine, lipiodol
Brief summary
Catheter directed retrograde venous infusion of gemcitabine/lipiodol into pancreatic tumors.
Detailed description
Overall, subjects with resectable, borderline-resectable and/or locally-advanced pancreatic cancer are eligible to be entered into the study. Each enrolled study subject will receive a single neoadjuvant pancreatic retrograde venous infusion (PRVI) administration of the gemcitabine/Lipiodol® emulsion. Complete enrollment in 12 months from date of enrollment of first study subject.
Interventions
DRUGRetrograde venous infusion of gemcitabine/lipiodol
Access will be gained into the portal vein via a transhepatic approach. The pancreatic tumor-draining veins will be accessed via a catheter positioned in the portal vein, superior mesenteric vein or splenic vein. The catheter is then advanced into the vein draining the segment in which the targeted tumor is located. Tumor location and its venous drainage will be confirmed with sub-selective pancreatic venography and cone-beam CT. Once correct catheter positioning is confirmed, the gemcitabine/Lipiodol® emulsion will be administered under real-time fluoroscopic guidance until the entire dose is administered or until stasis is achieved in the vein through which the drug is being delivered.
Sponsors
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is an open-label, single institution, single-arm pilot study, designed to assess the feasibility, safety and efficacy of retrograde venous infusion of gemcitabine/Lipiodol® administered in a neoadjuvant setting for the treatment of patients with resectable, borderline-resectable or locally-advanced pancreatic adenocarcinoma.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as determined by technical success of Pancreatic Retrograde Venous Infusion (PRVI) with gemcitabine and Lipiodol® | 30 days | Technical success is measured as number of participants who did not experience technical failure, which is defined as the inability to administer the gemcitabine/ Lipiodol® to the targeted pancreatic tumor. |
| Safety as measured by number of participants with Grade 3, 4, and 5 toxicities | 30 days | Number of participants with Grade 3, 4, and 5 toxicities as defined by the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE; Version 5.0) that occur during and within 30 days after PRVI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy as assessed by Objective tumor response | 30 days | Objective tumor response is measured as number of participants with response as determined by RECIST 1.1 criteria to assess change in tumor size and percent tumor enhancement as visualized on pancreatic protocol CT scans. |
| Efficacy as assessed by change in serum CA19-9 | Change from baseline to 30 days | Change in serum CA19-9 measurements pre- and post-PRVI. |
| Efficacy as assessed by change in levels of gemcitabine and dFdu in peripheral blood samples | Change from baseline to 30 days | Change in levels of gemcitabine and its inactive metabolite 2',2'-Difluorodeoxyuridine (dFdU) found in peripheral blood samples pre-and post-PRVI. |
Countries
United States
Outcome results
None listed