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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 : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Spectrum Health Hospitals

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

Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Liver Metastases Combination Product: FUDR via HAI pump Phase 2

Detailed Description:
This study hypothesizes that the combination of 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 be followed for two years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Floxuridine

Arm Intervention/treatment
Experimental: FUDR via HAI
This single treatment arm will deliver FUDR chemotherapy directly to the liver via a hepatic artery infusion (HAI) pump. The HAI pump is the intervention.
Combination Product: FUDR via HAI pump
Both 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 approved for this indication, although they are both approved for other indication. 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 Measures :
  1. 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). (If this explanation is too long - it won't fit in the blank - we can shorten it down, maybe remove the RECIST explanation part).


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. Rate of tumor response in the liver [ Time Frame: 2 years ]
    Determined by RECIST criteria on imaging studies done every 3 months

  4. EORTC Quality of Life Questionnarie [ Time Frame: 2 years ]
    As measured by the EORTC Quality of Life Questionnaire Core 30 instrument



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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 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 with RECIST read 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
  • MELD score >20, using the variables of bilirubin, serum sodium, 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

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: Gerald P. Wright, MD 616-486-6333 paul.wright@spectrumhealth.org
Contact: Marianne M 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: Gerald P. Wright, MD    616-486-6333    paul.wright@spectrumhealth.org   
Contact: Marianne M. Morrissey, BSN    616-391-1129    marianne.morrissey@spectrumhealth.org   
Sponsors and Collaborators
Spectrum Health Hospitals

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Responsible Party: Spectrum Health Hospitals
ClinicalTrials.gov Identifier: NCT03856658     History of Changes
Other Study ID Numbers: 2017-349
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Spectrum Health Hospitals:
pancreatic cancer, liver metastases, HAI, hepatic artery infusion pump
Additional relevant MeSH terms:
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Adenocarcinoma
Neoplasm Metastasis
Neoplasms, Second Primary
Pancreatic Neoplasms
Liver Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
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