Intraperitoneal Paclitaxel With NALIRIFOX for Pancreatic Ductal Adenocarcinoma With Peritoneal Carcinomatosis

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07030283
Phase
PHASE1
Status
Recruiting
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Conditions

  • Pancreatic Ductal Adenocarcinoma (PDAC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Dec 31, 2025
Status verified
Jan 2026
Primary completion
Jul 1, 2028
Completion
Jul 1, 2030

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intraperitoneal Paclitaxel with Systemic NALIRIFOX
    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.

Primary Outcome Measure

Adverse event rate [ Time Frame: From enrollment through 30 days after last dose of treatment administered (approximately 7 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Cancer CenterAuroraColorado80045
Puja Gupta Poddar
[email protected]
720-278-0236
Alexis Leal, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Colorado Cancer Center· Aurora, CO

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