Hepatic Artery Infusional Floxuridine to Treat Pancreatic Cancer Liver Metastases

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ClinicalTrials.gov Identifier: NCT03856658

Recruitment Status : Recruiting

First Posted : February 27, 2019

Last Update Posted : March 17, 2021

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Sponsor:

Information provided by (Responsible Party):

Spectrum Health Hospitals

Study Description

Brief Summary:

This is a single arm, phase II study without blinding. The purpose is to determine the impact of hepatic artery infusion Floxuridine (FUDR) on liver metastases from pancreatic adenocarcinoma. Patients at Spectrum Health will receive standard of care chemotherapy. They will also receive chemotherapy via surgically placed hepatic artery infusion (HAI) pump.

Condition or disease	Intervention/treatment	Phase
Pancreatic Adenocarcinoma Liver Metastases	Drug: Floxuridine (FUDR) Device: Hepatic Artery Infusion Pump Drug: Heparinized Saline	Phase 2

Detailed Description:

This study hypothesizes that the combination of Floxuridine (FUDR), a type of chemotherapy, delivered via a hepatic artery infusion (HAI) pump, with standard of care systemic chemotherapy will lead to improved survival in the treatment of pancreatic cancer liver metastases. Patients will receive 6 cycles of FUDR and will be followed for two years.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	15 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Intervention Model Description:	Single arm study without blinding
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase II Trial of Hepatic Artery Infusional Floxuridine With Systemic Chemotherapy in the Treatment of Pancreatic Cancer Liver Metastases
Actual Study Start Date :	February 5, 2019
Estimated Primary Completion Date :	April 2022
Estimated Study Completion Date :	April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatic Cancer

Drug Information available for: Floxuridine

Genetic and Rare Diseases Information Center resources: Pancreatic Cancer

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Floxuridine (FUDR) via HAI pump 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.	Drug: Floxuridine (FUDR) Together the FUDR and the HAI pump are experimental because they are being used to treat hepatic liver metastases of Pancreatic adenocarcinoma. They have not yet been FDA approved for this indication, although they are both approved for other indications. The intervention is surgical placement of an HAI pump with subsequent delivery of FUDR via the pump in 28-day cycles. FUDR will be delivered via the HAI pump for 6 months, in 28 day cycles: 2 weeks of therapy, followed by 2 weeks of heparinized saline. Other Name: FUDR Device: Hepatic Artery Infusion Pump Together the FUDR and the HAI pump are experimental because they are being used to treat hepatic liver metastases of Pancreatic adenocarcinoma. They have not yet been FDA approved for this indication, although they are both approved for other indications. The intervention is surgical placement of an HAI pump with subsequent delivery of FUDR via the pump in 28-day cycles. The primary tumor will be resected or ablated with irreversible electroporation at the time of HAI pump placement. FUDR will be delivered via the HAI pump for 6 months, in 28 day cycles: 2 weeks of therapy, followed by 2 weeks of heparinized saline. Other Names: HAI pump Medtronic pump Drug: Heparinized Saline Together the FUDR and the HAI pump are experimental because they are being used to treat hepatic liver metastases of Pancreatic adenocarcinoma. They have not yet been FDA approved for this indication, although they are both approved for other indications. FUDR will be delivered via the HAI pump for 6 months, in 28 day cycles: 2 weeks of therapy, followed by 2 weeks of heparinized saline.

Arm

Intervention/treatment

Experimental: Floxuridine (FUDR) via HAI pump

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.

Drug: Floxuridine (FUDR)

Together the FUDR and the HAI pump are experimental because they are being used to treat hepatic liver metastases of Pancreatic adenocarcinoma. They have not yet been FDA approved for this indication, although they are both approved for other indications. The intervention is surgical placement of an HAI pump with subsequent delivery of FUDR via the pump in 28-day cycles. FUDR will be delivered via the HAI pump for 6 months, in 28 day cycles: 2 weeks of therapy, followed by 2 weeks of heparinized saline.

Other Name: FUDR

Device: Hepatic Artery Infusion Pump

Together the FUDR and the HAI pump are experimental because they are being used to treat hepatic liver metastases of Pancreatic adenocarcinoma. They have not yet been FDA approved for this indication, although they are both approved for other indications. The intervention is surgical placement of an HAI pump with subsequent delivery of FUDR via the pump in 28-day cycles. The primary tumor will be resected or ablated with irreversible electroporation at the time of HAI pump placement. FUDR will be delivered via the HAI pump for 6 months, in 28 day cycles: 2 weeks of therapy, followed by 2 weeks of heparinized saline.

Other Names:

HAI pump
Medtronic pump

Drug: Heparinized Saline

Together the FUDR and the HAI pump are experimental because they are being used to treat hepatic liver metastases of Pancreatic adenocarcinoma. They have not yet been FDA approved for this indication, although they are both approved for other indications. FUDR will be delivered via the HAI pump for 6 months, in 28 day cycles: 2 weeks of therapy, followed by 2 weeks of heparinized saline.

Outcome Measures

Primary Outcome Measures :

Hepatic progression-free survival [ Time Frame: 1 year ]
The length of time from the start of trial therapy to the time when target liver lesions show progression or new lesions appear. (Determined by RECIST criteria: ≥20% growth in target lesions and/or appearance of new lesions).

Secondary Outcome Measures :

Overall survival [ Time Frame: 2 years ]
The length of time from diagnosis to death, measured as the proportion of patients surviving at specific time points (6, 12 and 18 months from diagnosis).
Progression-free survival at any site [ Time Frame: 2 years ]
The length of time from diagnosis to disease progression at any anatomical site (as determined by RECIST criteria) or death.
Rate of tumor response in the liver [ Time Frame: 2 years ]
Determined by RECIST criteria on imaging studies done every 3 months
EORTC Quality of Life Questionnaire [ Time Frame: 2 years ]
As measured by the EORTC Quality of Life Questionnaire Core 30 instrument

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Biopsy-proved pancreatic adenocarcinoma with synchronous liver metastases
Elevated Cancer Antigen 19-9 (CA19-9) at diagnosis (>37 U/mL)
Ages 18-75 years
Karnofsky performance status ≥70
Ability to undergo general anesthesia and HAI pump placement procedure
CT or MRI scan imaging of the abdomen demonstrating accessibility of the gastroduodenal artery within 2 months of enrollment
Received a minimum of 2 months of systemic chemotherapy with stable tumor markers and imaging.

Exclusion Criteria:

Primary tumor resected
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.
Greater than 60% liver parenchymal involvement by tumor
Evidence of peritoneal metastases
Current alcohol abuse
Pregnant or lactating women

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03856658

Contacts

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Contact: G. Paul Wright, MD	616-486-6333	paul.wright@spectrumhealth.org
Contact: Marianne Morrissey, BSN	616-391-1129	marianne.morrissey@spectrumhealth.org

Locations

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United States, Michigan
Spectrum Health	Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Murwarid M Assifi, MD 616-267-8540 mura.assifi@spectrumhealth.org
Contact: Amy E Pribyl, BSN 6164866111 amy.pribyl@spectrumhealth.org

Sponsors and Collaborators

Spectrum Health Hospitals

More Information

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Responsible Party:	Spectrum Health Hospitals
ClinicalTrials.gov Identifier:	NCT03856658
Other Study ID Numbers:	2017-349
First Posted:	February 27, 2019 Key Record Dates
Last Update Posted:	March 17, 2021
Last Verified:	April 2020

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	Yes
Product Manufactured in and Exported from the U.S.:	Yes

Keywords provided by Spectrum Health Hospitals:


pancreatic cancer, pancreatic ductal carcinoma, liver metastases, HAI, hepatic artery infusion pump, FUDR, Floxuridine

Additional relevant MeSH terms:

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Neoplasm Metastasis Neoplasms, Second Primary Pancreatic Neoplasms Liver Neoplasms Neoplasms Neoplastic Processes Pathologic Processes Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms	Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Liver Diseases Floxuridine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents

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