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A Pilot Protocol Evaluating Safety of the Medtronic Pump and Codman Catheter for the Delivery of Hepatic Arterial Infusion (HAI) Chemotherapy in Patients With Advanced Colorectal Carcinoma or Cholangiocarcinoma
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?
Details
| Lead sponsor | Benaroya Research Institute |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 100 |
| Start date | 2020-11-25 |
| Completion | 2024-12 |
Conditions
- Colorectal Cancer
- Cholangiocarcinoma
Interventions
- Medtronic pump and Codman catheter
- Floxuridine (FUDR)
- Gemcitabine
- Oxaliplatin
- Irinotecan (CPT-11)
- Fluorouracil
- Anti-EGFR (Panitumumab or Cetuximab)
Primary outcomes
- Number of patients requiring stent replacements — 1 year
- Percent frequency liver toxicity — 1 year
Alkaline phosphatase percent toxicity, Serum bilirubin percent toxicity
Countries
United States