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

Colorectal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04276090
• Other study ID #: MCC-19-GI-109-PMC
• Status: Terminated
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: June 14, 2022

Study information

• Verified date: July 2023
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: June 14, 2022
• Est. primary completion date: January 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bile Duct Neoplasms
• Cholangiocarcinoma
• Colorectal Neoplasms
• Neoplasm Metastasis
• Neoplasms

Intervention

Device:
• 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.

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

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Michael J Cavnar, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	approximately 4 weeks
Secondary	30-day Postoperative Serious Adverse Events Related to Pump Implantation	Tabulation of CTCAE serious adverse events attributed to pump implantation	30 days
Secondary	30-day Catheter Malfunction Due to Tubing Disconnect	Quantify the percent of patients with inability to meet primary outcome due to catheter disconnects.	30 days
Secondary	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.	30 days
Secondary	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.	Approximately 4 weeks
Secondary	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.	Immediate, determined at screening visit
Secondary	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.	Approximately 6 months
Secondary	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.	6 months
Secondary	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.	3 months
Secondary	Overall Response Rate at 6 Months	RECIST v1.1 will be used to assess overall response rate at 6 months.	6 months
Secondary	Percent of Patients Who Are Downstaged and Undergo Surgery	The percent of patients who are downstaged and undergo surgery will be tabulated.	6 months
Secondary	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.	6 months