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Device

Combined Infusion System for Hepatic Cancer

N/A

Recruiting

Research Sponsored by Ronald DeMatteo, M.D.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be greater than or equal to 18 years of age

At the time of pump placement, patients will either have unresectable, chemotherapy-responsive disease or they will be undergoing resection with planned postoperative HAI

Must not have

Known active infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from surgery up to 60 months post-surgery or study withdrawal

Awards & highlights

No Placebo-Only Group

Summary

This trial is for adults with colorectal cancer metastatic to the liver or intrahepatic cholangiocarcinoma who will receive the Medtronic SynchroMed II programmable pump combined with the Intera tapered catheter for hepatic artery infusion (HAI) of a standard chemotherapy (FUDR). The primary objective is to assess the safety of using this pump/catheter combination.

Who is the study for?

This trial is for adults with colorectal cancer that has spread to the liver or intrahepatic cholangiocarcinoma. Candidates should be suitable for pump chemotherapy, as determined by medical and surgical oncologists, and must consent to participate. They may have inoperable disease responding to chemotherapy or plan postoperative hepatic artery infusion.

What is being tested?

The study tests a Medtronic SynchroMed II programmable pump connected to an Intera tapered catheter system for delivering chemotherapy directly into the liver. The safety of this method using FUDR (a standard chemo drug) will be monitored through nuclear scans and routine imaging over up to five years.

What are the potential side effects?

While specific side effects are not listed, potential risks include complications from device implantation, reactions to the chemotherapy drug FUDR such as nausea or decreased blood counts, and issues related to the pump/catheter function which will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am getting a pump for my inoperable cancer that responds to chemo, or I am having surgery with planned chemo via a pump afterwards.

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My cancer started in the colon or rectum and has spread to the liver, or I have cancer that began in the liver's bile ducts.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have an active infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from surgery up to 60 months post-surgery or study withdrawal

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from surgery up to 60 months post-surgery or study withdrawal

This trial's timeline: 3 weeks for screening, Varies for treatment, and from surgery up to 60 months post-surgery or study withdrawal for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Targeted Adverse Events (TAEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Hepatic Artery Infusion (HAI) TherapyExperimental Treatment1 Intervention

Eligible patients will be implanted with a device that combines components of two commercially available drug delivery pumps to administer regional chemotherapy (FUDR) to the liver. Specifically, a Medtronic pump is being used with an Intera tapered catheter, instead of the Medtronic catheter.

0 / 4Eligibility criteria met