Actively Recruiting
Intraperitoneal Paclitaxel With NALIRIFOX for Pancreatic Ductal Adenocarcinoma With Peritoneal Carcinomatosis
Led by University of Colorado, Denver · Updated on 2026-02-02
10
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intraperitoneal Paclitaxel With NALIRIFOX for Pancreatic Ductal Adenocarcinoma With Peritoneal Carcinomatosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Willingness to sign and date the consent form
- Willingness to comply with all study procedures and be available for the study duration
- Histologically or cytologically confirmed pancreatic adenocarcinoma with cancer cells in the peritoneal cavity but no metastasis to other organs
- Primary tumor classified as resectable, borderline resectable, or locally advanced according to NCCN guidelines
- Peritoneal Cancer Index (PCI) score of 8 or less
- ECOG performance status of 0 or 1
- Prior treatment for 0 to 4 months with FOLFIRINOX, modified FOLFIRINOX, or NALIRIFOX and able to receive more treatment as decided by the investigator
- Adequate blood counts: absolute neutrophil count at least 1,500/mm3 without recent growth factors, platelet count at least 75,000/mm3, hemoglobin greater than 9 g/dL
- Adequate liver function: total bilirubin no more than 1.5 times the upper limit of normal, AST and ALT no more than 3 times the upper limit of normal
- Adequate kidney function: serum creatinine less than 1.5 times the upper limit of normal
You will not qualify if you...
- Prior surgery or investigational therapy for metastatic pancreatic cancer (biliary drainage, diagnostic laparoscopy/laparotomy, and duodenal stenting allowed)
- Presence of metastatic disease outside the peritoneal cavity
- Extensive metastatic disease in the peritoneal cavity with PCI score greater than 8
- Known progression of disease with any prior chemotherapy
- Allergy or hypersensitivity to paclitaxel or liposomal products
- Current use of strong CYP2C8 inhibitors or inducers, or other contraindications to paclitaxel
- Known UGT1A1 or DPD enzyme deficiency
- Neuropathy of grade 2 or higher
- Active symptomatic COVID-19 infection
- Previous or current radiation treatment for pancreatic cancer
- Receipt of live attenuated vaccine within 30 days before first intraperitoneal paclitaxel dose or planned during study
- Positive test for HIV or active hepatitis B or C infection (patients with treated and undetectable hepatitis B or C may enroll)
- Active infection at screening or treatment day that may affect participation or study results
- Any medical or social condition that might interfere with consent, cooperation, participation, or result interpretation
- Pregnant or breastfeeding; females of childbearing potential must have negative pregnancy test within 7 days before treatment and all reproductive-age participants must use highly effective contraception during and for 9 months after treatment
- Pancreatic tumors other than adenocarcinoma, such as neuroendocrine or acinar carcinoma
- Signs or symptoms suggesting unacceptable disease worsening at screening
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
P
Puja Gupta Poddar
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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