Clinical trial NCT04276090: 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
Overall status: TERMINATED
Phase: NA
Conditions: Bile Duct Neoplasms
Colorectal Neoplasms
Keywords: hepatic artery infusion pump
colorectal liver metastases
intrahepatic cholangiocarcinoma
FUDR
floxuridine
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percent Completion of 1st Cycle of Hepatic Artery Chemotherapy
timeFrame: approximately 4 weeks
Secondary outcomes:
measure: 30-day Postoperative Serious Adverse Events Related to Pump Implantation
timeFrame: 30 days
measure: 30-day Catheter Malfunction Due to Tubing Disconnect
timeFrame: 30 days
measure: 30-day Catheter Malfunction Due to Inability to Access Pump
timeFrame: 30 days
measure: Percent of Patients That Require Secondary Intervention in Order to Obtain Primary Pump Function.
timeFrame: Approximately 4 weeks
measure: Percent of Screened Patients That Are Declined Due to High Risk of Failure as Determined by the Psychosocial Assessment Tool.
timeFrame: Immediate, determined at screening visit
measure: Percent Pump Loss Due to Inability to Attend Scheduled Followup Appointments.
timeFrame: Approximately 6 months
measure: Number of Interventions (Phone Calls) to Assure Patients Attend Followup Appointments.
timeFrame: 6 months
measure: Percent of Patients Who Remain on Hepatic Artery Infusion Pump Chemotherapy at 3 Months.
timeFrame: 3 months
measure: Overall Response Rate at 6 Months
timeFrame: 6 months
measure: Percent of Patients Who Are Downstaged and Undergo Surgery
timeFrame: 6 months
measure: Percent of Patients Who Remain on Hepatic Artery Infusion Pump Chemotherapy at 6 Months.
timeFrame: 6 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Michael J Cavnar, MD
role: PRINCIPAL_INVESTIGATOR
References: