Clinical trial NCT03865563: Selective Transvenous Chemoembolization of Primary Pancreatic Tumors
Official title: Selective Transvenous Chemoembolization of Primary Pancreatic Tumors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Pancreatic Adenocarcinoma
Keywords: retrograde venous infusion
chemotherapy
gemcitabine
lipiodol
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility 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 \[\> grade 1, according to the National Cancer Institute Common Toxicity Criteria v5.0 (CTAE v5.0)\]

Primary outcomes:
measure: Feasibility as determined by technical success of Pancreatic Retrograde Venous Infusion (PRVI) with gemcitabine and Lipiodol®
timeFrame: 30 days
measure: Safety as measured by number of participants with Grade 3, 4, and 5 toxicities
timeFrame: 30 days
Secondary outcomes:
measure: Efficacy as assessed by Objective tumor response
timeFrame: 30 days
measure: Efficacy as assessed by change in serum CA19-9
timeFrame: Change from baseline to 30 days
measure: Efficacy as assessed by change in levels of gemcitabine and dFdu in peripheral blood samples
timeFrame: Change from baseline to 30 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Robert P Liddell, MD
role: PRINCIPAL_INVESTIGATOR
References: