Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Rare Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Cholangiocarcinoma

Bile Duct Neoplasms

Neoplastic Processes

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Biliary Tract Neoplasms

Bile Duct Diseases

Biliary Tract Diseases

Bile Duct Cancer

Intrahepatic Cholangiocarcinoma

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Oxaliplatin

Dexamethasone acetate

Liver Extracts

Panitumumab

Floxuridine

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Antimetabolites

Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type)

Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone)

Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.

Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.

Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump

Hepatic artery infusion pump floxuridine and dexamethasone

Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)

Systemic chemotherapy for colorectal liver metastases

Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)

Systemic chemotherapy for intrahepatic cholangiocarcinoma

Michael J Cavnar, MD

Due to discontinuation of the Codman C3000 pump, an alternate device is necessary to continue serving patients in need of hepatic arterial infusion chemotherapy. This study aims to test the safety of hepatic artery infusion pump placement, a standard surgical procedure, and intraarterial chemotherapy initiation with the standard medication floxuridine (FUDR), using the Medtronic Synchromed II pump combined with the Codman arterial catheter in patients with unresectable (not removable by surgery) liver metastases from colorectal cancer and unresectable intrahepatic cholangiocarcinoma. This study will determine if complication and pump loss rates will be similar to previously published rates for the Codman system.

Patients with unresectable colorectal liver metastases (arm 1) and unresectable intrahepatic cholangiocarcinoma (arm 2), will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. All patients will receive hepatic artery infusion floxuridine, and then individual arms will receive disease-specific systemic chemotherapy.

Codman Catheter/Synchromed Pump Hepatic Artery Chemotherapy for Unresectable Colorectal Metastases/Intrahepatic Cholangiocarcinoma

Feasibility Pilot of Hepatic Arterial Infusion Chemotherapy in a Rural Catchment Area, Using the Codman Vascular Catheter With the Synchromed II Pump, for Patients With Unresectable Colorectal Cancer Liver Metastases or Unresectable Intrahepatic Cholangiocarcinoma

The percent of patients who complete the 1st cycle of hepatic artery chemotherapy will be tabulated. This is a conglomerate safety endpoint which is a surrogate for any complication that prevents delivery of hepatic artery chemotherapy via the device combination.

Tabulation of CTCAE serious adverse events attributed to pump implantation

Quantify the percent of patients with inability to meet primary outcome due to catheter disconnects.

Quantify the percent of patients with inability to meet primary outcome due to inability to access pump.

Percentage of patients who need secondary intervention (IR embolization, revision of pump or tubing) to achieve primary pump function.

Patients are screen using a psychosocial assessment tool for high risk of hepatic artery pump loss/failure, percent declined will be tabulated.

Percent of patients that experience pump loss/failure due to inability to attend scheduled followup appointments will be tabulated.

The number of staff contacts (phone calls) to assure patients keep their followup visits will be tabulated.

The percentage of patients who remain on pump chemotherapy at 3 months will be tabulated.

RECIST v1.1 will be used to assess overall response rate at 6 months.

The percent of patients who are downstaged and undergo surgery will be tabulated.

The percentage of patients who remain on pump chemotherapy at 6months will be tabulated.

Assistant Professor

Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type)

Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.

Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump

Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)

Colorectal Liver Metastases

Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone)

Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.

Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump

Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)

Total

40-70 years

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Michael Cavnar

Percent Completion of 1st Cycle of Hepatic Artery Chemotherapy

30-day Postoperative Serious Adverse Events Related to Pump Implantation

30-day Catheter Malfunction Due to Tubing Disconnect

30-day Catheter Malfunction Due to Inability to Access Pump

Percent of Patients That Require Secondary Intervention in Order to Obtain Primary Pump Function.

Percent of Screened Patients That Are Declined Due to High Risk of Failure as Determined by the Psychosocial Assessment Tool.

Percent Pump Loss Due to Inability to Attend Scheduled Followup Appointments.

Number of Interventions (Phone Calls) to Assure Patients Attend Followup Appointments.

Percent of Patients Who Remain on Hepatic Artery Infusion Pump Chemotherapy at 3 Months.

At the 6 month time point for this outcome there were only 14 evaluable participants for response rate due to attrition, death, or sub-RECIST threshold disease.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Codman Catheter/Synchromed Pump Hepatic Artery Chemotherapy for Unresectable Colorectal Metastases/Intrahepatic Cholangiocarcinoma	NCT04276090	Bile Duct Neopl... Colorectal Neop...	Hepatic artery ... Hepatic artery ... Systemic chemot... Systemic chemot...	18 Years -	University of Kentucky
Codman Catheter/Synchromed Pump Hepatic Artery Chemotherapy for Unresectable Colorectal Metastases/Intrahepatic Cholangiocarcinoma	NCT04276090	Bile Duct Neopl... Colorectal Neop...	Hepatic artery ... Hepatic artery ... Systemic chemot... Systemic chemot...	18 Years -	University of Kentucky

Spots Global Cancer Trial Database for systemic chemotherapy for intrahepatic cholangiocarcinoma