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

Primary Purpose

Bile Duct Neoplasms, Colorectal Neoplasms

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone
Systemic chemotherapy for colorectal liver metastases
Systemic chemotherapy for intrahepatic cholangiocarcinoma
Sponsored by
Michael J Cavnar, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bile Duct Neoplasms focused on measuring hepatic artery infusion pump, colorectal liver metastases, intrahepatic cholangiocarcinoma, FUDR, floxuridine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients ≥ 18 years of age
  • Histologically confirmed unresectable colorectal adenocarcinoma metastatic to the liver with no definitive clinical or radiographic evidence of extrahepatic disease. Clinical or radiographic evidence of metastatic disease to peri-hepatic lymph nodes will be allowed, provided it is amenable to resection.

(OR)

  • Histologically confirmed unresectable non-metastatic intrahepatic cholangiocarcinoma, with presence of less than 70% liver involvement. Clinical or radiographic evidence of metastatic disease to peri-hepatic lymph nodes will be allowed, provided it is amenable to resection.
  • ECOG Performance Status of 0 - 1
  • Lab Values ≤ 14 days prior to study enrollment:

absolute neutrophil count ≥1,500/mcL AST/ALT < 2.5 x institutional upper limit of normal (ULN) Platelets ≥ 100,000/mcL Creatinine < 1.5 mg/dL HGB > 9 g/dL Total Bilirubin ≤ 1.5 mg/dL

  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • Prior chemotherapy is acceptable if last dose given ≥ 3 weeks prior to study enrollment.
  • Any investigational agent is acceptable if last dose administered ≥ 3 months before study enrollment.

Exclusion Criteria:

  • Presence of distant metastatic disease confirmed by radiographic evaluation. Clinical or radiographic evidence of metastatic disease to regional peri-hepatic lymph nodes will be allowed, provided it is amenable to resection.
  • Prior radiation to the liver, including external beam, SBRT, Y90. Prior radiation therapy to the pelvis is acceptable.
  • Active infection, hepatic encephalopathy
  • Clinical evidence of portal hypertension (ascites, gastroesophageal varices or portal vein thrombosis; surgically-related ascites does not exclude the patient)
  • Female patients who are pregnant or lactating - or planning to become pregnant within 6 months after the end of the treatment (female patients of child-bearing potential must have negative pregnancy test ≤72 hours before surgery)
  • If in the opinion of the treating investigator a patient has any serious medical problems which may preclude receiving this type of treatment
  • Patients with history or known presence of primary CNS tumors, seizures not well-controlled with standard medical therapy, or history of stroke
  • Serious or non-healing active wound, ulcer, or bone fracture
  • Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the HAIP chemotherapy (i.e., investigational regimen)
  • Patients with psychiatric illness or social situations that would limit compliance with study requirements. Examples include: active substance abuse, active severe EtOH abuse, etc.
  • Inability to reliably commit to traveling to Lexington, KY every 2 weeks for duration of the study treatment (6 months). Patient must have readily identifiable, reliable primary and back-up modes of transportation regardless of weather.

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Colorectal liver metastases

Intrahepatic cholangiocarcinoma

Arm Description

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)

Outcomes

Primary Outcome Measures

Percent Completion of 1st Cycle of Hepatic Artery Chemotherapy
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.

Secondary Outcome Measures

30-day Postoperative Serious Adverse Events Related to Pump Implantation
Tabulation of CTCAE serious adverse events attributed to pump implantation
30-day Catheter Malfunction Due to Tubing Disconnect
Quantify the percent of patients with inability to meet primary outcome due to catheter disconnects.
30-day Catheter Malfunction Due to Inability to Access Pump
Quantify the percent of patients with inability to meet primary outcome due to inability to access pump.
Percent of Patients That Require Secondary Intervention in Order to Obtain Primary Pump Function.
Percentage of patients who need secondary intervention (IR embolization, revision of pump or tubing) to achieve primary pump function.
Percent of Screened Patients That Are Declined Due to High Risk of Failure as Determined by the Psychosocial Assessment Tool.
Patients are screen using a psychosocial assessment tool for high risk of hepatic artery pump loss/failure, percent declined will be tabulated.
Percent Pump Loss Due to Inability to Attend Scheduled Followup Appointments.
Percent of patients that experience pump loss/failure due to inability to attend scheduled followup appointments will be tabulated.
Number of Interventions (Phone Calls) to Assure Patients Attend Followup Appointments.
The number of staff contacts (phone calls) to assure patients keep their followup visits will be tabulated.
Percent of Patients Who Remain on Hepatic Artery Infusion Pump Chemotherapy at 3 Months.
The percentage of patients who remain on pump chemotherapy at 3 months will be tabulated.
Overall Response Rate at 6 Months
RECIST v1.1 will be used to assess overall response rate at 6 months.
Percent of Patients Who Are Downstaged and Undergo Surgery
The percent of patients who are downstaged and undergo surgery will be tabulated.
Percent of Patients Who Remain on Hepatic Artery Infusion Pump Chemotherapy at 6 Months.
The percentage of patients who remain on pump chemotherapy at 6months will be tabulated.

Full Information

First Posted
February 16, 2020
Last Updated
July 12, 2023
Sponsor
Michael J Cavnar, MD
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1. Study Identification

Unique Protocol Identification Number
NCT04276090
Brief Title
Codman Catheter/Synchromed Pump Hepatic Artery Chemotherapy for Unresectable Colorectal Metastases/Intrahepatic Cholangiocarcinoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
an alternate device became FDA approved
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
January 4, 2022 (Actual)
Study Completion Date
June 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael J Cavnar, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bile Duct Neoplasms, Colorectal Neoplasms
Keywords
hepatic artery infusion pump, colorectal liver metastases, intrahepatic cholangiocarcinoma, FUDR, floxuridine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colorectal liver metastases
Arm Type
Experimental
Arm Description
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)
Arm Title
Intrahepatic cholangiocarcinoma
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Intervention Description
Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Intervention Type
Drug
Intervention Name(s)
Hepatic artery infusion pump floxuridine and dexamethasone
Intervention Description
Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Intervention Type
Drug
Intervention Name(s)
Systemic chemotherapy for colorectal liver metastases
Intervention Description
Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
Intervention Type
Drug
Intervention Name(s)
Systemic chemotherapy for intrahepatic cholangiocarcinoma
Intervention Description
Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)
Primary Outcome Measure Information:
Title
Percent Completion of 1st Cycle of Hepatic Artery Chemotherapy
Description
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.
Time Frame
approximately 4 weeks
Secondary Outcome Measure Information:
Title
30-day Postoperative Serious Adverse Events Related to Pump Implantation
Description
Tabulation of CTCAE serious adverse events attributed to pump implantation
Time Frame
30 days
Title
30-day Catheter Malfunction Due to Tubing Disconnect
Description
Quantify the percent of patients with inability to meet primary outcome due to catheter disconnects.
Time Frame
30 days
Title
30-day Catheter Malfunction Due to Inability to Access Pump
Description
Quantify the percent of patients with inability to meet primary outcome due to inability to access pump.
Time Frame
30 days
Title
Percent of Patients That Require Secondary Intervention in Order to Obtain Primary Pump Function.
Description
Percentage of patients who need secondary intervention (IR embolization, revision of pump or tubing) to achieve primary pump function.
Time Frame
Approximately 4 weeks
Title
Percent of Screened Patients That Are Declined Due to High Risk of Failure as Determined by the Psychosocial Assessment Tool.
Description
Patients are screen using a psychosocial assessment tool for high risk of hepatic artery pump loss/failure, percent declined will be tabulated.
Time Frame
Immediate, determined at screening visit
Title
Percent Pump Loss Due to Inability to Attend Scheduled Followup Appointments.
Description
Percent of patients that experience pump loss/failure due to inability to attend scheduled followup appointments will be tabulated.
Time Frame
Approximately 6 months
Title
Number of Interventions (Phone Calls) to Assure Patients Attend Followup Appointments.
Description
The number of staff contacts (phone calls) to assure patients keep their followup visits will be tabulated.
Time Frame
6 months
Title
Percent of Patients Who Remain on Hepatic Artery Infusion Pump Chemotherapy at 3 Months.
Description
The percentage of patients who remain on pump chemotherapy at 3 months will be tabulated.
Time Frame
3 months
Title
Overall Response Rate at 6 Months
Description
RECIST v1.1 will be used to assess overall response rate at 6 months.
Time Frame
6 months
Title
Percent of Patients Who Are Downstaged and Undergo Surgery
Description
The percent of patients who are downstaged and undergo surgery will be tabulated.
Time Frame
6 months
Title
Percent of Patients Who Remain on Hepatic Artery Infusion Pump Chemotherapy at 6 Months.
Description
The percentage of patients who remain on pump chemotherapy at 6months will be tabulated.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients ≥ 18 years of age Histologically confirmed unresectable colorectal adenocarcinoma metastatic to the liver with no definitive clinical or radiographic evidence of extrahepatic disease. Clinical or radiographic evidence of metastatic disease to peri-hepatic lymph nodes will be allowed, provided it is amenable to resection. (OR) Histologically confirmed unresectable non-metastatic intrahepatic cholangiocarcinoma, with presence of less than 70% liver involvement. Clinical or radiographic evidence of metastatic disease to peri-hepatic lymph nodes will be allowed, provided it is amenable to resection. ECOG Performance Status of 0 - 1 Lab Values ≤ 14 days prior to study enrollment: absolute neutrophil count ≥1,500/mcL AST/ALT < 2.5 x institutional upper limit of normal (ULN) Platelets ≥ 100,000/mcL Creatinine < 1.5 mg/dL HGB > 9 g/dL Total Bilirubin ≤ 1.5 mg/dL Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load Prior chemotherapy is acceptable if last dose given ≥ 3 weeks prior to study enrollment. Any investigational agent is acceptable if last dose administered ≥ 3 months before study enrollment. Exclusion Criteria: Presence of distant metastatic disease confirmed by radiographic evaluation. Clinical or radiographic evidence of metastatic disease to regional peri-hepatic lymph nodes will be allowed, provided it is amenable to resection. Prior radiation to the liver, including external beam, SBRT, Y90. Prior radiation therapy to the pelvis is acceptable. Active infection, hepatic encephalopathy Clinical evidence of portal hypertension (ascites, gastroesophageal varices or portal vein thrombosis; surgically-related ascites does not exclude the patient) Female patients who are pregnant or lactating - or planning to become pregnant within 6 months after the end of the treatment (female patients of child-bearing potential must have negative pregnancy test ≤72 hours before surgery) If in the opinion of the treating investigator a patient has any serious medical problems which may preclude receiving this type of treatment Patients with history or known presence of primary CNS tumors, seizures not well-controlled with standard medical therapy, or history of stroke Serious or non-healing active wound, ulcer, or bone fracture Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the HAIP chemotherapy (i.e., investigational regimen) Patients with psychiatric illness or social situations that would limit compliance with study requirements. Examples include: active substance abuse, active severe EtOH abuse, etc. Inability to reliably commit to traveling to Lexington, KY every 2 weeks for duration of the study treatment (6 months). Patient must have readily identifiable, reliable primary and back-up modes of transportation regardless of weather.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Cavnar, MD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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