Floxuridine for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

Overseen byG. Paul Wright, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Spectrum Health Hospitals

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I have pancreatic cancer that has spread to my liver.

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

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

+4 more

Exclusion Criteria

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

My primary tumor has been surgically removed.

My cancer has spread to the lining of my abdomen.

+3 more

Participant Groups

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.

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.