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

NCT04276090 | Terminated Results DMC FDA Device

• 1 other identifier: MCC-19-GI-109-PMC
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Bile Duct Neoplasms; Colorectal Neoplasms

Keywords

hepatic artery infusion pump; colorectal liver metastases; intrahepatic cholangiocarcinoma; FUDR; floxuridine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 30-day Postoperative Serious Adverse Events Related to Pump Implantation

  30 days

• 30-day Catheter Malfunction Due to Tubing Disconnect

  30 days

• 30-day Catheter Malfunction Due to Inability to Access Pump

  30 days

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

  Approximately 4 weeks

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

  Immediate, determined at screening visit

Study Arms (2)

Colorectal liver metastases

EXPERIMENTAL

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)

Device: Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.; Drug: Hepatic artery infusion pump floxuridine and dexamethasone; Drug: Systemic chemotherapy for colorectal liver metastases

Intrahepatic cholangiocarcinoma

EXPERIMENTAL

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)

Device: Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.; Drug: Hepatic artery infusion pump floxuridine and dexamethasone; Drug: Systemic chemotherapy for intrahepatic cholangiocarcinoma

Interventions

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

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

Colorectal liver metastases; Intrahepatic cholangiocarcinoma

Hepatic artery infusion pump floxuridine and dexamethasone DRUG

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

Colorectal liver metastases; Intrahepatic cholangiocarcinoma

Systemic chemotherapy for colorectal liver metastases DRUG

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

Systemic chemotherapy for intrahepatic cholangiocarcinoma DRUG

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

Intrahepatic cholangiocarcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michael J Cavnar, MD: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Publications (1)

• McDonald HG, Cassim EB, Harper MM, Burke EE, Marcinkowski EF, Cavnar MJ, Pandalai PK, Kim J. The Development of Investigator-Initiated Clinical Trials in Surgical Oncology. Surg Oncol Clin N Am. 2023 Jan;32(1):13-25. doi: 10.1016/j.soc.2022.07.003. Epub 2022 Nov 3.

  PMID: 36410913 DERIVED

MeSH Terms

Conditions

Bile Duct Neoplasms; Colorectal Neoplasms; Cholangiocarcinoma

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr. Michael Cavnar
• Organization: University of Kentucky

michael.cavnar@uky.edu

859-323-8920

Study Officials

• Michael J Cavnar, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 16, 2020
• First Posted: February 19, 2020
• Study Start: May 1, 2020
• Primary Completion: January 4, 2022
• Study Completion: June 14, 2022
• Last Updated: July 25, 2023
• Results First Posted: January 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)