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A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma

NCT04668976 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-12-21

No results posted yet for this study

Summary

This study is being done to answer the following question:

Is the combination of the Medtronic pump and the Codman catheter device a safe alternative to the C3000 Codman pump for delivering chemotherapy directly into the liver of patients with metastatic colorectal cancer or cholangiocarcinoma?

Conditions

Interventions

DEVICE

Medtronic pump and Codman catheter

All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.

DRUG

Floxuridine (FUDR)

Please see Detailed Description.

DRUG

Gemcitabine

Please see Detailed Description.

DRUG

Oxaliplatin

Please see Detailed Description.

DRUG

Irinotecan (CPT-11)

Please see Detailed Description.

DRUG

Fluorouracil

Please see Detailed Description.

DRUG

Anti-EGFR (Panitumumab or Cetuximab)

Please see Detailed Description.

Sponsors & Collaborators

  • Virginia Mason Hospital/Medical Center

    collaborator OTHER

  • Benaroya Research Institute

    lead OTHER

Principal Investigators

  • Hagen Kennecke, MD · Virginia mason medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-25
Primary Completion
2023-12-31
Completion
2024-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04668976 on ClinicalTrials.gov