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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Benaroya Research Institute
Study ID
NCT04668976
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Medtronic pump and Codman catheter — DEVICE
    All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
  • Floxuridine (FUDR) — DRUG
    Please see Detailed Description.
  • Gemcitabine — DRUG
    Please see Detailed Description.
  • Oxaliplatin — DRUG
    Please see Detailed Description.
  • Irinotecan (CPT-11) — DRUG
    Please see Detailed Description.
  • Fluorouracil — DRUG
    Please see Detailed Description.
  • Anti-EGFR (Panitumumab or Cetuximab) — DRUG
    Please see Detailed Description.

Study Details

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?

Key Dates

Start date
Nov 25, 2020
Status verified
Dec 2020
Primary completion
Dec 31, 2023
Completion
Dec 31, 2024

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Number of patients requiring stent replacements [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia mason medical CenterSeattleWashington98101
Hagen Kennecke, MD
[email protected]
206-223-6193
Hagen Kennecke, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Seattle, WA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Virginia mason medical Center· Seattle, WA

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