Intraperitoneal Paclitaxel With Standard Systemic NALIRIFOX for Pancreatic Ductal Adenocarcinoma With Peritoneal Carcinomatosis: Prospective Pilot Trial
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.
• Provision to sign and date the consent form.
• Stated willingness to comply with all study procedures and be available for the duration of the study.
• Be age 18 years or older.
• Histologically or cytologically confirmed pancreatic adenocarcinoma with histologically or cytologically proven seeding in the peritoneal cavity without metastasis to other organs.
• Primary tumor that is resectable, borderline resectable, or locally advanced per NCCN classification.
• PCI score ≤ 8.
• ECOG performance status of 0 or 1
• Prior treatment for 0-4 months with FOLFIRINOX, modified FOLFIRINOX, or NALIRIFOX and able to receive additional treatment per investigator opinion
• Adequate biological parameters as evidenced by all of the following blood counts:
‣ Absolute neutrophil count (ANC) \>/= 1,500 per cubic millimeter without the use of hematopoietic growth factors within 14 days prior to screening
⁃ Platelet count \>/= 75,000 per cubic millimeter
⁃ Hemoglobin \> 9 g/dL
⁃ Adequate hepatic function as evidenced by:
∙ Serum total bilirubin ≤ 1.5x ULN (biliary drainage is allowed for biliary obstruction), and
‣ AST and ALT ≤ 3 x ULN
⁃ Adequate renal function as evidenced by serum creatinine \<1.5 x ULN