NALIRIFOX + Paclitaxel for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a combination of two chemotherapy treatments, NALIRIFOX and Paclitaxel, is safe and effective for individuals with pancreatic cancer that has spread to the abdomen. One drug is administered directly into the abdomen, while the other is given through a vein. Participants will receive regular treatments and undergo checkups, imaging scans, and lab tests to evaluate the treatment's effectiveness. This trial may suit those with pancreatic cancer confined to the abdomen who have already received treatment for up to four months without progression. The goal is to discover a better treatment option that might improve survival and quality of life and potentially make surgery an option for more individuals. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this potentially groundbreaking therapy.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you are using strong CYP2C8 inhibitors or inducers, as these can interfere with paclitaxel, one of the trial drugs.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Studies have shown that administering paclitaxel directly into the abdomen is generally well-tolerated. Some patients experienced side effects like abdominal pain or bloating, but these were usually manageable. Research indicates that this method maintains high drug levels at the cancer site, effectively targeting tumors.
The NALIRIFOX regimen, used intravenously for pancreatic cancer, has received FDA approval for cases where the cancer has spread, indicating its safety and effectiveness. Previous patients experienced side effects like nausea or fatigue, common with chemotherapy, but these were often manageable with supportive care.
Both treatments have been tested in various settings and have demonstrated a safety profile suitable for clinical trials. While side effects can occur, many patients manage them with appropriate care and monitoring.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of NALIRIFOX and Paclitaxel for pancreatic cancer because it introduces a novel delivery method that could enhance treatment effectiveness. Unlike the standard of care, which often includes systemic chemotherapy, this approach uses intraperitoneal delivery for Paclitaxel, allowing the drug to target cancer cells directly in the abdominal cavity. Additionally, NALIRIFOX combines multiple active ingredients—Fluorouracil, Leucovorin, Liposomal Irinotecan, and Oxaliplatin—which together may enhance cancer cell destruction. This combination could potentially offer a more robust attack on pancreatic cancer compared to existing treatments.
What evidence suggests that this treatment might be an effective treatment for pancreatic cancer?
In this trial, participants will receive a combination of treatments: Intraperitoneal Paclitaxel and Systemic NALIRIFOX. Research has shown that delivering paclitaxel directly into the abdominal area can effectively target cancers that have spread there. For example, one study found that 61% of patients survived for at least one year, with some able to undergo surgery later. Meanwhile, NALIRIFOX, a combination of chemotherapy drugs administered intravenously, has shown promising results in increasing survival rates and enabling more patients to undergo surgery. Specifically, another study reported a 26% one-year survival rate for this treatment in advanced pancreatic cancer cases. Together, these treatments aim to aggressively tackle pancreatic cancer, offering hope for better outcomes.12367
Who Is on the Research Team?
Alexis Leal, MD
Principal Investigator
University of Colorado, Denver
Are You a Good Fit for This Trial?
Adults with pancreatic cancer that has spread to the peritoneum are eligible for this trial. They must be able to tolerate a combination drug regimen and agree to receive treatments via an abdominal port and intravenous infusions, attend regular clinic visits, undergo imaging and lab tests, and complete questionnaires.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intraperitoneal paclitaxel on days 1 and 8 and intravenous NALIRIFOX on day 1 of each 14-day cycle, for up to 12 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment, including imaging scans, blood lab testing, and quality of life assessments
Conversion Surgery (optional)
Participants may undergo surgery if the cancer responds well to treatment
What Are the Treatments Tested in This Trial?
Interventions
- NALIRIFOX
- Paclitaxel
Trial Overview
The trial is testing if giving paclitaxel directly into the abdomen combined with NALIRIFOX through a vein every two weeks can safely treat pancreatic cancer in the peritoneum. It also evaluates whether patients might become candidates for surgery after treatment.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
Citations
Intraperitoneal Paclitaxel Treatment for Patients with ...
Intraperitoneal administration of paclitaxel was developed to enhance antitumor activity against peritoneal dissemination by maintaining a high ...
Efficacy and safety of intraperitoneal chemotherapy for ...
A systematic review and meta-analysis on peritoneal malignancies of different origins showed a one-year survival rate of 37% in patients with ...
NCT07030283 | Intraperitoneal Paclitaxel With NALIRIFOX ...
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 ...
Intraperitoneal paclitaxel: pharmacology, clinical results and ...
Free intraperitoneal cancer cells could not be recovered following EPIC paclitaxel. One-year survival was 90.5% and 3-year survival was 29.8%. The authors ...
Phase I/II study of adding intraperitoneal paclitaxel in patients ...
The median survival time was 14·5 months, and the 1-year overall survival rate was 61 per cent. Conversion surgery was performed in eight of 46 ...
Intraperitoneal and intravenous paclitaxel plus S-1 versus ...
As of data cutoff (March 9, 2024), the median survival time was 19.4 months (95% CI, 17.1~22.9), in the NIPS group and 13.9 months (95% CI, 10.3 ...
Intraperitoneal chemotherapy for pancreatic cancer with ...
The median progression free survival (PFS) for all 25 patients was 6.1 months, and the median OS was 17.3 months. The median PFS and OS for the chemotherapy- ...
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