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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
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.
University of Colorado Cancer Center
Aurora, Colorado, United States
RECRUITINGAdverse event rate
Time frame: From enrollment through 30 days after last dose of treatment administered (approximately 7 months)
1-year survival rate
Time frame: From enrollment through 12 months after the last dose of treatment (approximately 18 months)
Overall survival
Time frame: From enrollment through 24 months after the last dose of treatment (approximately 30 months)
Progression-free survival
Time frame: From enrollment through end of treatment (approximately 6 months)
Objective response rate
Time frame: From enrollment through end of treatment (approximately 6 months)
Change in peritoneal carcinomatosis index
The peritoneal carcinomatosis index is a score used to assess the amount of cancer in the peritoneal cavity. The score ranges from 0 to 39, with a higher score indicating a greater extent of cancer.
Time frame: From enrollment to 6 months after end of treatment (approximately 12 months)
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