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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing whether Floxuridine given through a hepatic artery infusion pump can improve outcomes for patients with liver metastases from pancreatic adenocarcinoma. Patients will receive standard of care chemotherapy along with the Floxuridine.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hepatic progression-free survival

Secondary outcome measures

EORTC Quality of Life Questionnaire

Overall survival

Progression-free survival at any site

+1 more

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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Spectrum Health HospitalsLead Sponsor

64 Previous Clinical Trials

553,194 Total Patients Enrolled

G. Paul Wright, MDPrincipal InvestigatorCorewell Health

1 Previous Clinical Trials

16 Total Patients Enrolled

Media Library

Floxuridine (FUDR) (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03856658 — Phase 2

Pancreatic Adenocarcinoma Research Study Groups: Floxuridine (FUDR) via HAI pump

Pancreatic Adenocarcinoma Clinical Trial 2023: Floxuridine (FUDR) Highlights & Side Effects. Trial Name: NCT03856658 — Phase 2

Floxuridine (FUDR) (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03856658 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any eligibility requirements to become involved in this scientific investigation?

"As indicated by the study's criteria, to qualify for this medical trial patients must have hepatic metastases and be between 18-75 years of age. The current enrolment goal is 15 participants."

Answered by AI

What is the magnitude of participants involved in this research endeavor?

"Yes, clinicaltrials.gov confirms this study is actively seeking participants; the initial posting was on February 5th 2019 and it has most recently been updated on November 22nd 2022. 15 people are required to be enrolled from 1 site."

Answered by AI

Has Floxuridine (FUDR) received regulatory accreditation from the Food and Drug Administration?

"Our team at Power has rated the safety of Floxuridine (FUDR) a 2 due to clinical evidence testifying its security, although there is yet no proof that it works in this particular case."

Answered by AI

Does the protocol of this clinical trial afford participation to those above 18 years old?

"According to the trial parameters, individuals must be between 18 and 75 years old in order to qualify for enrollment."

Answered by AI

Is there currently any availability for enrollment in this investigation?

"Affirmative. According to clinicaltrials.gov, the trial which was initially published on February 5th 2019 is actively recruiting participants. This project requires 15 individuals from a single medical site for enrollment."

Answered by AI

To what extent has Floxuridine (FUDR) been explored in medical research?

"Currently, 17 clinical studies are actively examining the effects of Floxuridine (FUDR). 4 trials have reached phase 3 with 42 sites operating throughout the United States. Many locations for this research can be found in Basking Ridge, New jersey."

Answered by AI