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
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Adenocarcinoma Liver Metastases||Combination Product: FUDR via HAI pump||Phase 2|
|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)|
|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|
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.
- 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).
- 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 Questionnarie [ Time Frame: 2 years ]As measured by the EORTC Quality of Life Questionnaire Core 30 instrument
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
|Contact: Gerald P. Wright, MDfirstname.lastname@example.org|
|Contact: Marianne M Morrissey, BSNemail@example.com|
|United States, Michigan|
|Grand Rapids, Michigan, United States, 49503|
|Contact: Gerald P. Wright, MD 616-486-6333 firstname.lastname@example.org|
|Contact: Marianne M. Morrissey, BSN 616-391-1129 email@example.com|