Intraperitoneal Paclitaxel With NALIRIFOX for Pancreatic Ductal Adenocarcinoma With Peritoneal Carcinomatosis

NCT07030283 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 24-2111.cc
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Keywords

Peritoneal Carcinomatosis; pancreatic adenocarcinoma; pancreatic ductal adenocarcinoma; PDAC; metastatic; NALIRIFOX; intraperitoneal chemotherapy; intraperitoneal paclitaxel; circulating tumor DNA (ctDNA); peritoneal cell-free DNA

Outcome Measures

Primary Outcomes (1)

• Adverse event rate

  From enrollment through 30 days after last dose of treatment administered (approximately 7 months)

Secondary Outcomes (5)

• 1-year survival rate

  From enrollment through 12 months after the last dose of treatment (approximately 18 months)

• Overall survival

  From enrollment through 24 months after the last dose of treatment (approximately 30 months)

• Progression-free survival

  From enrollment through end of treatment (approximately 6 months)

• Objective response rate

  From enrollment through end of treatment (approximately 6 months)

• Change in peritoneal carcinomatosis index

  From enrollment to 6 months after end of treatment (approximately 12 months)

Other Outcomes (7)

• Changes in serum circulating tumor DNA

  From enrollment to end of treatment (approximately 6 months)

• Conversion surgery rate

  From enrollment to end of treatment (approximately 6 months)

• Change in quality of life assessed by EORTC QLQ-C30 questionnaire

  From enrollment to 6 months after end of treatment (approximately 12 months)

Study Arms (1)

Intraperitoneal Paclitaxel with Systemic NALIRIFOX

EXPERIMENTAL

Intraperitoneal paclitaxel will be administered on days 1 and 8 via the intraperitoneal port, and systemic NALIRIFOX (Fluorouracil Continuous Infusion/Leucovorin/Liposomal Irinotecan/Oxaliplatin) will be administered on day 1 of each 14-day cycle. The maximum treatment duration is 12 cycles.

Drug: Paclitaxel; Drug: NALIRIFOX

Interventions

Paclitaxel DRUG

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.

Also known as: Taxol

Intraperitoneal Paclitaxel with Systemic NALIRIFOX

NALIRIFOX DRUG

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.

Intraperitoneal Paclitaxel with Systemic NALIRIFOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior treatment of pancreatic cancer in the metastatic setting with surgery or investigational therapy (Note: biliary drainage, diagnostic laparoscopy/laparotomy, and duodenal stenting is allowed).
• Evident distant metastatic disease outside of the peritoneal cavity.
• Extensive metastatic disease in peritoneal cavity (PCI\>8).
• Known disease progression with any prior chemotherapy.
• Known hypersensitivity to paclitaxel or other liposomal products.
• Current use of strong CYP2C8 inhibitors or inducers, or presence of any other contraindications for paclitaxel.
• Known UGT1A1 deficiency or DPD deficiency.
• Neuropathy Grade 2 or higher
• Known active COVID infection with symptoms.
• Has ever received or is currently receiving radiation for pancreatic cancer treatment.
• Receipt of live, attenuated vaccine within 30 days prior the first dose of Intraperitoneal paclitaxel. (Note: enrolled patients should not receive live vaccines during the study and up to 30 days after the last dose of intraperitoneal paclitaxel).
• Known positive test results for human immunodeficiency (HIV) or patients with chronic or active hepatitis B or C. Patients who have a history of hepatitis B or C who have undetectable HBV DNA or HCV RNA after anti-viral therapy may be enrolled.
• Active infection during screening visits or on the day of treatment, which in the investigator's opinion might compromise the patient's participation in the trial or affect the study outcome.
• Any other medical or social condition deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
• Pregnant or breast feeding; females of child-bearing potential must test negative for pregnancy within 7 days prior to C1D1. Both male and female patients of reproductive potential must agree to use a highly effective method of birth control during the study and for 9 months following the last dose of both IP PTX and IV NALIRIFOX.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Peritoneal Neoplasms; Neoplasm Metastasis

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Alexis Leal, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Puja Gupta Poddar

CONTACT

720-278-0236; puja.guptapoddar@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 22, 2025
• Study Start: December 31, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2030
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

US (1)