Selective Transvenous Chemoembolization of Primary Pancreatic Tumors

Pancreatic Adenocarcinoma Clinical Trial

Official title:

Selective Transvenous Chemoembolization of Primary Pancreatic Tumors

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03865563
• Other study ID #: J1936
• Secondary ID: IRB00164996
• Status: Withdrawn
• Phase: Phase 1
• Start date: July 2019
• Est. completion date: December 2021

Study information

• Verified date: January 2020
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)]

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma
• Pancreatic Neoplasms

Intervention

Drug:
• Retrograde 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.

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as determined by technical success of Pancreatic Retrograde Venous Infusion (PRVI) with gemcitabine and Lipiodol®	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.	30 days
Primary	Safety as measured by number of participants with Grade 3, 4, and 5 toxicities	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	30 days
Secondary	Efficacy as assessed by Objective tumor response	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.	30 days
Secondary	Efficacy as assessed by change in serum CA19-9	Change in serum CA19-9 measurements pre- and post-PRVI.	Change from baseline to 30 days
Secondary	Efficacy as assessed by change in levels of gemcitabine and dFdu in peripheral blood samples	Change in levels of gemcitabine and its inactive metabolite 2',2'-Difluorodeoxyuridine (dFdU) found in peripheral blood samples pre-and post-PRVI.	Change from baseline to 30 days