Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04270929
Other study ID # 342-30
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date December 23, 2019
Est. completion date May 4, 2021

Study information

Verified date May 2021
Source Roger Williams Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is an open label, single institution, dose-escalation phase 1 study designed to assess the feasibility, safety, and efficacy of oxaliplatin administered via Pancreatic Retrograde Venous Infusion (PRVI) using Pressure Enabled Drug Delivery (PEDD) technology. Oxaliplatin PEDD-PRVI is administered with systemic FOLFIRI followed by FOLFIRINOX therapy for the treatment of patients with unresectable or metastatic pancreatic adenocarcinoma.


Description:

The treatment period consists of 6 cycles. Cycles 1 and 2 involve the regional administration of oxaliplatin via PEDD-PRVI with systemic FOLFIRI. During cycles 1 and 2, patients are evaluated on days 1, 2, 4, and 8. Cycles 3 through 6 include the systemic administration of standard of care FOLFIRINOX. During cycles 3 through 6, patients are evaluated on days 1 and 8.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 4, 2021
Est. primary completion date May 4, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Patient with histologically confirmed diagnosis of adenocarcinoma of the pancreas. Patient must have either histologic confirmation of the primary tumor or metastasis. - Patients must have locally advanced, unresectable or metastatic pancreatic adenocarcinoma. - Patient must be between 18 - 80 years of age. - Patient able to understand and sign informed consent. - Patient may be chemotherapy naïve or may have failed one line of conventional therapy - Prior FOLFIRINOX therapy: - Patients who have previously received FOLFIRINOX chemotherapy for locally advanced unresectable pancreatic cancer are eligible for enrollment upon this study if they meet the following criteria- 1. FOLFIRINOX chemotherapy was completed more than six months ago, 2. Patients who are currently candidates for re-challenge with FOLFIRINOX chemotherapy for their recurrent cancer, and 3. Patients have no persistent non-hematologic toxicity greater than grade 1 (due to prior FOLFIRINOX therapy) - Patients with metastatic cancer who are currently receiving FOLFIRINOX chemotherapy are eligible for enrollment upon this study if they meet the following criteria- 1. Patients have received no more than six cycles of FOLFIRINOX chemotherapy, 2. Patients have at least stable disease on imaging, and 3. Patients have no persistent non-hematologic toxicity greater than grade 1 (due to ongoing FOLFIRINOX therapy) - Patient with a life expectancy of greater than six months. - Patient with performance status of 0 to 1 (ECOG). - All patients must have adequate organ function as defined by: - ANC greater than or equal to 1500/mm3, platelets = 100,000/mm3, Hgb = to 8 g/dL; patient may be transfused to achieve Hgb = 8 g/dL to satisfy enrollment criteria, or as otherwise indicated by symptoms for Hgb > 8 g/dL. - Creatinine = 1.5mg/dl or creatinine clearance = 60cc/min. - Direct bilirubin <1.5X ULN, alkaline phosphatase <5X ULN, and ALT/AST <5X ULN (ULN = upper limit of normal). - No evidence of congestive heart failure, symptoms of coronary artery disease, serious cardiac arrhythmias, including uncontrolled atrial fibrillation/atrial flutter, evidence of prior myocardial infarction by history or EKG. - No serious, symptomatic obstructive or emphysematous lung disease, or asthma requiring intravenous medications within the past 12 months; no serious lung disease associated with dyspnea at normal activity levels (grade III) or at rest (grade IV), due to any cause (including cancer metastases and pleural effusions). - Acceptable vascular anatomy as determined by CT, MR, or conventional venography. Exclusion Criteria: - Female patients of childbearing age will be tested for pregnancy. Pregnant and breastfeeding patients will be excluded from the study. Males who are actively seeking to have children will be made aware of the unknown risks of this study protocol on human sperm and the need to practice birth control. - Patients with serious or unstable renal, hepatic, pulmonary, cardiovascular, endocrine, rheumatologic, or allergic disease based on history, physical exam and laboratory tests will be excluded. - Patients with uncontrolled diabetes mellitus or a history of pancreatitis. - Patients with cholelithiasis and a history of choledocholithiasis. - Patients with concurrent malignancies, except for cutaneous carcinomas. - Patients with unsuitable vascular anatomy. - Portal vein occlusion/thrombosis, history of portal hypertension, cirrhosis, hepatitis, or with radiographic evidence of cirrhosis.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
FOLFIRI
During Cycles 1 and 2, standard of care systemic FOLFIRI will be delivered on Days 2-4 following oxaliplatin PEDD-PRVI.
FOLFIRINOX
During Cycles 3-6, standard of care systemic FOLFIRINOX will be administered on Days 1-3.
Device:
TriSalus Infusion System
The TriSalus Infusion System administers therapeutics using PEDD technology.

Locations

Country Name City State
United States Roger Williams Medical Center Providence Rhode Island

Sponsors (2)

Lead Sponsor Collaborator
Roger Williams Medical Center TriSalus Life Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Completion Rate of oxaliplatin PEDD-PRVI To determine the completion rate of oxaliplatin delivery by PEDD-PRVI as measured by the percentage of successful placements of the TriSalus Infusion System and delivery of the assigned dose of oxaliplatin regionally into the pancreas via RVI per each patient, at each dose-level, and across all enrolled patients in the study. Successful delivery of oxaliplatin by PEDD-PRVI will be confirmed using real-time fluoroscopic guidance. The success rate of completion of PEDD-RVI per patient and acroos all-patients will be calculated 3 months
Primary Safety of oxaliplatin PEDD-PRVI: maximum tolerable dose (MTD) To determine the safety of oxaliplatin PEDD-PRVI by identifying the maximum tolerable dose (MTD). 3 months
Secondary To determine local progression free survival Assess the time frame of pancreatic tumor stability prior to progression by radiographic imaging 3 months
Secondary To determine systemic progression free survival. Assess the time frame of metastatic tumor stability prior to progression by radiographic imaging 3 months
Secondary To determine overall survival As a measure of activity, overall survival will be assessed. The events for the assessment of overall survival are death events. 3 months
Secondary Radiographic response rates by PET Changes in tumor metabolic activity 3 months
Secondary Radiographic response rate by perfusion MRI Changes in tumor size 3 months
Secondary Serologic response rates (CA 19-9) Serial measurement of serum CA 19-9 levels 3 months
See also
  Status Clinical Trial Phase
Completed NCT05305001 - Germline Mutations Associated With Hereditary Pancreatic Cancer in Unselected Patients With Pancreatic Cancer in Mexico
Recruiting NCT05059444 - ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Completed NCT01959672 - Chemotherapy, Stereotactic Body Radiation Therapy & Nelfinavir Mesylate in Locally Advanced Pancreatic Cancer Phase 2
Recruiting NCT03673423 - Evaluation of the Interobserver Agreement on the Resectability Status of Patients With a Pancreatic Cancer
Terminated NCT02495896 - Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors Phase 1
Recruiting NCT05351983 - Patient-derived Organoids Drug Screen in Pancreatic Cancer N/A
Not yet recruiting NCT06026943 - Alpha Radiation Emitters Device for the Treatment of Pancreatic Cancer Emitters for the Treatment of Locally Advanced Pancreatic Cancer N/A
Completed NCT03054987 - Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography for Malignant Distal Biliary Obstruction N/A
Terminated NCT02345460 - Preoperative Folfirinox for Resectable Pancreatic Adenocarcinoma - A Phase II Study Phase 2
Recruiting NCT02072616 - Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma. Phase 3
Completed NCT02174887 - Biological Effect of Nab-paclitaxel Combined to Gemcitabine in Metastatic Pancreatic Cancer Phase 1
Recruiting NCT03703063 - Alternative Neoadjuvant Chemotherapy in Resectable and Borderline Resectable Pancreatic Cancer Phase 1
Terminated NCT04077372 - Assessment of a Serious Illness Conversation Guide (SICG) in Advanced Gastro-Intestinal Cancers N/A
Recruiting NCT03073785 - Hypofractionated Stereotactic Body Radiation & Fluorouracil or Capecitabine for Locally Advanced Pancreatic Cancer Phase 2
Completed NCT03665441 - Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment in PAC Phase 3
Recruiting NCT04627246 - Personalized Vaccine With SOC Chemo Followed by Nivo in Pancreatic Cancer Phase 1
Not yet recruiting NCT06217666 - Study Examining the Safety and Toxicity of Stereotactic Body Radiotherapy (SBRT) Followed by PCX12 Immunotherapy Delivered by Intratumoral Injection for the Treatment of Patients With Locally Advanced Pancreatic Adenocarcinoma (LAPC) Phase 1
Recruiting NCT05585320 - A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT04119362 - PARAGON Platform for Outcome, Quality of Life, and Translational Research on Pancreatic Cancer
Completed NCT03105921 - Irreversible Electroporation (NanoKnife) for the Treatment of Pancreatic Adenocarcinoma N/A