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Hepatic Artery Infusional Floxuridine to Treat Pancreatic Cancer Liver Metastases

Primary Purpose

Pancreatic Adenocarcinoma, Liver Metastases

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Floxuridine (FUDR)
Hepatic Artery Infusion Pump
Heparinized Saline
Sponsored by
Spectrum Health Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Adenocarcinoma focused on measuring pancreatic cancer, pancreatic ductal carcinoma, liver metastases, HAI, hepatic artery infusion pump, FUDR, Floxuridine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Spectrum HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Floxuridine (FUDR) via HAI pump

Arm Description

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.

Outcomes

Primary Outcome Measures

Hepatic progression-free survival
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
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
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
Determined by RECIST criteria on imaging studies done every 3 months
EORTC Quality of Life Questionnaire
As measured by the EORTC Quality of Life Questionnaire Core 30 instrument

Full Information

First Posted
February 25, 2019
Last Updated
August 3, 2023
Sponsor
Spectrum Health Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT03856658
Brief Title
Hepatic Artery Infusional Floxuridine to Treat Pancreatic Cancer Liver Metastases
Official Title
A Phase II Trial of Hepatic Artery Infusional Floxuridine With Systemic Chemotherapy in the Treatment of Pancreatic Cancer Liver Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 5, 2019 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spectrum Health Hospitals

4. Oversight

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

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma, Liver Metastases
Keywords
pancreatic cancer, pancreatic ductal carcinoma, liver metastases, HAI, hepatic artery infusion pump, FUDR, Floxuridine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Single arm study without blinding
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Floxuridine (FUDR) via HAI pump
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Floxuridine (FUDR)
Other Intervention Name(s)
FUDR
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Hepatic Artery Infusion Pump
Other Intervention Name(s)
HAI pump, Medtronic pump
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Heparinized Saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hepatic progression-free survival
Description
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).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Overall survival
Description
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).
Time Frame
2 years
Title
Progression-free survival at any site
Description
The length of time from diagnosis to disease progression at any anatomical site (as determined by RECIST criteria) or death.
Time Frame
2 years
Title
Rate of tumor response in the liver
Description
Determined by RECIST criteria on imaging studies done every 3 months
Time Frame
2 years
Title
EORTC Quality of Life Questionnaire
Description
As measured by the EORTC Quality of Life Questionnaire Core 30 instrument
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
G. Paul Wright, MD
Phone
616-486-6333
Email
paul.wright@spectrumhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Esther Peariso, MSN, RN
Phone
6164860358
Email
esther.peariso@corewellhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G. Paul Wright, MD
Organizational Affiliation
Corewell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Murwarid M Assifi, MD
Phone
616-267-8540
Email
mura.assifi@spectrumhealth.org
First Name & Middle Initial & Last Name & Degree
Esther L Peariso, BSN
Phone
616-486-0358
Email
esther.peariso@corewellhealth.org

12. IPD Sharing Statement

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Hepatic Artery Infusional Floxuridine to Treat Pancreatic Cancer Liver Metastases

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