Chemotherapy with Medtronic Pump and Codman Catheter for Colorectal Cancer

Recruiting in Palo Alto (17 mi)

Overseen byHagen Kennecke, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Benaroya Research Institute

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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?

Research Team

Hagen Kennecke, MD

Principal Investigator

Virginia mason medical Center

Eligibility Criteria

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.

Inclusion Criteria

ALK PHOS 0 to < 1.2 x reference value

My colorectal cancer has spread to my liver and not beyond.

I am 18 years old or older.

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Exclusion Criteria

I have not had radiation to the liver, but may have had pelvic radiation completed over 4 weeks ago.

I have had cancer before, but it was a different type than my current diagnosis.

I do not have any serious wounds, ulcers, or unhealed bone fractures.

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Treatment Details

Interventions

Floxuridine (FUDR) (Anti-metabolites)
Fluorouracil (Anti-metabolites)
Gemcitabine (Alkylating agents)
Irinotecan (CPT-11) (Alkylating agents)
Medtronic pump and Codman catheter (Procedure)
Oxaliplatin (Alkylating agents)
Panitumumab or Cetuximab (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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.