RecruitingPhase 1NCT07030283

Intraperitoneal Paclitaxel With NALIRIFOX for Pancreatic Ductal Adenocarcinoma With Peritoneal Carcinomatosis

Intraperitoneal Paclitaxel With Standard Systemic NALIRIFOX for Pancreatic Ductal Adenocarcinoma With Peritoneal Carcinomatosis: Prospective Pilot Trial


Sponsor

University of Colorado, Denver

Enrollment

10 participants

Start Date

Dec 31, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This goal of this clinical trial is to learn whether the drug combination of intraperitoneal paclitaxel (chemotherapy given directly into the abdominal cavity) and intravenous NALIRIFOX (chemotherapy given into a vein, including fluorouracil, leucovorin, oxaliplatin, and liposomal irinotecan) is safe and works in adults with pancreatic cancer that has spread to the peritoneum. The main questions it aims to answer are: * Are people with pancreatic cancer able to tolerate the combination drug regimen? * How well does the combination drug regimen work to treat pancreatic cancer? Participants will: * Obtain a port that goes into the abdomen to deliver intraperitoneal paclitaxel (called an intraperitoneal catheter) * Receive treatment with intravenous NALIRIFOX once every 2 weeks and intraperitoneal paclitaxel on days 1 and 8 of each 14-day cycle * Visit the clinic with each treatment for checkups and laboratory testing * Have imaging scans and blood lab testing to determine response to treatment * Have abdominal fluid lab testing that may help determine if the cancer is responding to treatment * Fill out questionnaires to see how the treatment affects how participants feel and function * Continue follow up after treatment ends to track survival Some participants may be able to have surgery later if the cancer responds well. This is called conversion surgery. To be eligible for surgery, the cancer must have shrunk or stayed the same, peritoneal fluid (from the abdomen) must no longer show cancer cells, and a tumor marker called CA 19-9 must decrease or return to normal. The decision to do surgery will depend on the treating surgeon. By testing this new treatment strategy, researchers hope to find a safer and more effective way to treat people with pancreatic cancer that has spread to the abdomen. If successful, this approach may lead to longer survival, better quality of life, and more people becoming eligible for surgery.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of chemotherapy delivered directly into the abdominal cavity (intraperitoneal paclitaxel) along with a standard chemotherapy regimen (NALIRIFOX) for people with pancreatic cancer that has spread to the lining of the abdomen (peritoneal carcinomatosis). **You may be eligible if:** - You are 18 or older - You have been diagnosed with pancreatic adenocarcinoma with cancer spread to the lining of your abdomen (but not to other organs) - Your primary tumor is potentially removable or at the boundary of resectability - You have received 0 to 4 months of prior FOLFIRINOX or NALIRIFOX chemotherapy - You are in good physical health **You may NOT be eligible if:** - Your cancer has spread to organs outside the abdomen - You have had previous abdominal surgeries that make the procedure risky - You have significant organ dysfunction (liver, kidney, blood) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPaclitaxel

Paclitaxel is a chemotherapy medication that is FDA-approved to treat a number of cancer types. In this study, paclitaxel will be administered via the intraperitoneal port. Intraperitoneal paclitaxel is not FDA approved for pancreatic cancer.

DRUGNALIRIFOX

NALIRIFOX is a systemic chemotherapy treatment for metastatic pancreatic cancer that was approved by the FDA in February 2024. It's a combination of drugs that are already approved to treat pancreatic cancer: Liposomal irinotecan (Nal-IRI or Onivyde®), 5 fluorouracil (5-FU)/leucovorin, and Oxaliplatin.


Locations(1)

University of Colorado Cancer Center

Aurora, Colorado, United States

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NCT07030283


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