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Anti-metabolites

Chemotherapy with Medtronic Pump and Codman Catheter for Colorectal Cancer

Phase 2
Recruiting
Led By Hagen Kennecke, MD
Research Sponsored by Benaroya Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinically or radiographically confirmed extrahepatic disease
Participants ≥18 years of age
Must not have
Serious or non-healing active wound, ulcer, or bone fracture
Malignancy treated with curative intent and with no known active disease present for ≥3 years prior to registration and felt to be at low risk for recurrence by the treating physician
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is testing whether a Medtronic pump and Codman catheter device is a safe alternative to the C3000 Codman pump for delivering chemotherapy directly into the liver for patients with metastatic colorectal cancer or cholangiocarcinoma.

Who is the study for?
This trial is for adults with colorectal cancer or cholangiocarcinoma that has spread to the liver, without extrahepatic disease. Participants must have acceptable organ function and performance status, may have had prior chemotherapy but not recent radiation to the liver, and should not be pregnant or planning pregnancy soon.
What is being tested?
The study tests if using a Medtronic pump with a Codman catheter is safe for delivering chemotherapy directly into the liver compared to the standard C3000 Codman pump in patients with specific types of liver metastases.
What are the potential side effects?
Potential side effects include those common to chemotherapy such as nausea, vomiting, diarrhea, low blood counts leading to increased infection risk or bleeding problems, fatigue, and possible complications from device use like infection at the catheter site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My colorectal cancer has spread to my liver and not beyond.
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I am 18 years old or older.
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I had my last chemotherapy with oxaliplatin or irinotecan more than 3 weeks ago.
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I am fully active and can carry on all pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any serious wounds, ulcers, or unhealed bone fractures.
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My cancer was treated over 3 years ago, with no current signs of it and considered low risk for coming back.
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My colorectal cancer is either BRAF mutant or has mismatch repair issues.
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My cervical cancer was treated and shows no signs of being present.
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I had skin cancer (not melanoma) or lentigo maligna, but it's now treated with no signs of the disease.
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I do not have a history of brain tumors, uncontrolled seizures, or strokes.
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I do not have an active infection, fluid in my abdomen, or brain issues due to liver disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent frequency liver toxicity
Secondary study objectives
Overall survival
Progression free survival

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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: Pump TherapyExperimental Treatment7 Interventions
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
FDA approved
Floxuridine
FDA approved
Medtronic pump and Codman catheter
2018
Completed Phase 2
~40
Gemcitabine
FDA approved
Fluorouracil
FDA approved
Cetuximab
FDA approved
Oxaliplatin
FDA approved

Find a Location

Who is running the clinical trial?

Benaroya Research InstituteLead Sponsor
49 Previous Clinical Trials
12,157 Total Patients Enrolled
Virginia Mason Hospital/Medical CenterOTHER
22 Previous Clinical Trials
8,426 Total Patients Enrolled
Hagen Kennecke, MDPrincipal InvestigatorVirginia mason medical Center
6 Previous Clinical Trials
618 Total Patients Enrolled

Media Library

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Colorectal Cancer Research Study Groups: Pump Therapy
Colorectal Cancer Clinical Trial 2023: Floxuridine (FUDR) Highlights & Side Effects. Trial Name: NCT04668976 — Phase 2
Floxuridine (FUDR) (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04668976 — Phase 2
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