Combined Infusion System to Deliver Chemotherapy Regionally to the Liver

This clinical trial studies the side effects of a combined infusion system composed of a Medtronic pump and Intera tapered catheter, which delivers chemotherapy directly to the liver. The Medtronic pump works by releasing cancer-fighting drugs into the body in a controlled manner. The Intera catheter carries drugs from the pump’s reservoir to one of the blood vessels that supplies your liver. The reservoir holds a supply of a cancer-fighting drug.

Inclusion Criteria

Patients must be >= 18 years of age
Have a clinical or biopsy-proven diagnosis of colorectal cancer metastatic to liver or intrahepatic cholangiocarcinoma
At the time of pump placement, patients will either have unresectable, chemotherapy-responsive disease or they will be undergoing resection with planned postoperative hepatic artery infusion (HAI)
Be deemed appropriate for pump chemotherapy by both a medical oncologist and a surgical oncologist
Provision of signed and dated informed consent form

Exclusion Criteria

Known active infection
Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the trial

Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04684862.

PRIMARY OBJECTIVE:

I. Safety of the combination of the Medtronic pump with the Intera catheter.

OUTLINE:

Patients undergo surgical implantation of Medtronic pump connected to a Intera tapered catheter on day 0. Beginning 4-9 weeks, patients receive floxuridine continuously over 2 weeks every other two weeks.

Trial PhaseNo phase specified

Trial Typetreatment

Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center

Principal InvestigatorRonald Paul DeMatteo

Primary IDUPCC 19220
Secondary IDsNCI-2021-01368
ClinicalTrials.gov IDNCT04684862

Combined Infusion System to Deliver Chemotherapy Regionally to the Liver

Inclusion Criteria

Exclusion Criteria

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Combined Infusion System to Deliver Chemotherapy Regionally to the Liver

Description

Eligibility Criteria

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Trial Objectives and Outline

Trial Phase & Type

Lead Organization

Trial IDs

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