Intraperitoneal Paclitaxel with NALIRIFOX for the Treatment of Resectable, Borderline Resectable, or Locally Advanced Pancreatic Ductal Adenocarcinoma with Peritoneal Carcinomatosis
This phase I trial tests the safety and side effects of intraperitoneal (IP) paclitaxel in combination with fluorouracil, leucovorin, liposomal irinotecan, and oxaliplatin (NALIRIFOX) and how well the combination works in treating patients with pancreatic ductal adenocarcinoma (PDAC) that has spread extensively throughout the peritoneum (peritoneal carcinomatosis) and can be removed by surgery (resectable), that may be between resectable and unresectable (borderline resectable) or that has spread to nearby tissue or lymph nodes (locally advanced). The peritoneum is the tissue that lines the abdominal wall and covers most of the organs in the abdomen and is the second most common site of metastatic spread in pancreatic cancer. Cancer that has spread extensively throughout the peritoneum is known as peritoneal carcinomatosis and has a worse prognosis than other metastatic sites. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Giving paclitaxel closer to the tumor location in the abdomen (intraperitoneal) may work better to treat the tumor. Fluorouracil, a type of antimetabolite, stops cells from making deoxyribonucleic acid (DNA) and it may kill tumor cells. Leucovorin calcium (leucovorin), a form of folic acid, is a drug used to lessen the toxic effects of substances that block the action of folic acid. It is a type of chemoprotective agent and a type of chemosensitizing agent. Liposomal irinotecan is a form of the anticancer drug irinotecan hydrochloride that is contained inside very tiny, fat-like particles. Liposomal irinotecan blocks a certain enzyme needed for cell division and DNA repair, and it may kill tumor cells. It is a type of topoisomerase inhibitor and a type of camptothecin analog. Liposomal irinotecan may have fewer side effects and work better than other forms of irinotecan hydrochloride. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell’s DNA and may kill tumor cells. Giving intraperitoneal paclitaxel in combination with NALIRIFOX may be safe, tolerable and/or effective in treating patients with resectable, borderline resectable, or locally advanced PDAC and peritoneal carcinomatosis.