What is the mechanism of action of this treatment?

Common treatments for Pancreatic Adenocarcinoma, such as hepatic artery infusion of Floxuridine, work by directly delivering chemotherapeutic agents to liver metastases, thereby increasing local drug concentration and inhibiting DNA synthesis in cancer cells. This targeted approach aims to maximize the therapeutic effect on liver tumors while minimizing systemic toxicity. Systemic therapies like FOLFIRINOX and gemcitabine-based regimens also play a crucial role by interfering with DNA replication and repair mechanisms, thus preventing cancer cell proliferation. These treatments are vital for Pancreatic Adenocarcinoma patients as they can improve survival rates and manage symptoms more effectively.

What side effects are associated with this type of intervention?

Common treatments for Pancreatic Adenocarcinoma, such as Hepatic Artery Infusion Floxuridine, gemcitabine, and combination regimens like FOLFIRINOX, are associated with several side effects. These include nausea, diarrhea, neutropenia, thrombocytopenia, fatigue, neuropathy, and abdominal pain. Specifically, gemcitabine-based therapies can cause severe fatigue, nausea/vomiting, and neutropenia, while FOLFIRINOX is known for its high incidence of neurotoxicity and gastrointestinal symptoms. Hepatic Artery Infusion Floxuridine may also lead to localized side effects such as abdominal pain due to the direct delivery of the chemotherapeutic agent to the liver.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic adenocarcinoma, including systemic chemotherapy regimens such as FOLFIRINOX (a combination of fluorouracil, leucovorin, irinotecan, and oxaliplatin) and gemcitabine-based therapies. These treatments aim to inhibit DNA synthesis and cell division. While hepatic artery infusion of Floxuridine (FUDR) specifically targets liver metastases by delivering the chemotherapeutic agent directly to the liver, this method is still under investigation and not yet FDA-approved for pancreatic adenocarcinoma. Current FDA-approved treatments focus on systemic administration rather than localized delivery to liver metastases.

What other types of research exist?

Promising alternatives to Hepatic Artery Infusion Floxuridine for pancreatic adenocarcinoma include: 1) FOLFIRINOX (a combination of 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin), which has shown significant efficacy in advanced pancreatic cancer; 2) Gemcitabine combined with nab-paclitaxel, which has been effective in improving survival rates; 3) Immunotherapy approaches, such as immune checkpoint inhibitors (e.g., pembrolizumab) for patients with specific genetic markers; and 4) Targeted therapies, including PARP inhibitors for patients with BRCA mutations. These alternatives offer a range of systemic and targeted treatment options that may be beneficial for pancreatic adenocarcinoma patients.

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Anti-metabolites

Floxuridine for Pancreatic Cancer

Phase 2

Recruiting

Led By G. Paul Wright, MD

Research Sponsored by Spectrum Health Hospitals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biopsy-proved pancreatic adenocarcinoma with synchronous liver metastases

Received a minimum of 2 months of systemic chemotherapy with stable tumor markers and imaging.

Must not have

Model for End Stage Liver Disease (MELD) score >20, using the variables of: Bilirubin, serum Sodium, International Normalized Ratio (INR), serum Creatinine, and Dialysis twice in the past week.

Primary tumor resected

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial is testing a new way to treat pancreatic cancer that has spread to the liver. Patients will receive a special chemotherapy drug directly into their liver through a pump, along with their usual chemotherapy. The goal is to see if this method helps them live longer.

Who is the study for?

This trial is for adults aged 18-75 with pancreatic cancer that has spread to the liver. They must have a specific tumor marker level (CA19-9 >37 U/mL), be able to undergo surgery for a chemo pump, and have had at least 2 months of stable disease on standard chemo.

What is being tested?

The study tests Floxuridine chemotherapy delivered directly into the liver through an infusion pump, alongside standard care. It's a phase II trial without placebo control, aiming to see how well this method works on liver metastases from pancreatic cancer.

What are the potential side effects?

Floxuridine may cause side effects like inflammation in the liver, pain or complications from the pump placement surgery, and typical chemotherapy-related issues such as nausea, fatigue, low blood counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have pancreatic cancer that has spread to my liver.

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I've had at least 2 months of chemotherapy with no worsening of my cancer.

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I can safely undergo general anesthesia and have a pump placed inside me.

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I am able to care for myself but may not be able to do active work.

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver disease is severe, with a MELD score over 20.

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My primary tumor has been surgically removed.

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My cancer has spread to the lining of my abdomen.

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More than 60% of my liver is affected by cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hepatic progression-free survival

Secondary study objectives

EORTC Quality of Life Questionnaire

Overall survival

Progression-free survival at any site

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Floxuridine (FUDR) via HAI pumpExperimental Treatment3 Interventions

Once enrolled, patients will undergo surgical placement of the HAI pump. This can be accomplished using minimally invasive or open techniques with an anticipated hospital stay of approximately 3-5 days. Prior to discharge from the hospital or at the first postoperative visit the pump is filled with FUDR according to the following equation: 0.12 mg/kg/d (using ideal body weight). This fill initiates day 1 of a 4-week cycle. The chemotherapy is infused by the pump continuously over 14 days. On day 15 (+/-4 days), the remaining chemotherapy is removed from the pump which is refilled with heparinized saline (30,000 units). This remains for an additional 2 weeks until the pump is refilled with FUDR at the start of the next cycle. Treatment is continued for a maximum of 6 cycles or as limited by toxicity. This regimen has been utilized with an acceptable safety profile in the setting of colorectal liver metastases.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Floxuridine

FDA approved

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Pancreatic Adenocarcinoma, such as hepatic artery infusion of Floxuridine, work by directly delivering chemotherapeutic agents to liver metastases, thereby increasing local drug concentration and inhibiting DNA synthesis in cancer cells. This targeted approach aims to maximize the therapeutic effect on liver tumors while minimizing systemic toxicity. Systemic therapies like FOLFIRINOX and gemcitabine-based regimens also play a crucial role by interfering with DNA replication and repair mechanisms, thus preventing cancer cell proliferation. These treatments are vital for Pancreatic Adenocarcinoma patients as they can improve survival rates and manage symptoms more effectively.

[Regional intra-arterial infusion chemotherapy for pancreatic cancer: an experimental study].