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

  • STATUS
    Recruiting
  • End date
    Mar 15, 2026
  • participants needed
    34
  • sponsor
    Michael J Cavnar, MD
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Updated on 16 February 2024
See if I qualify
dexamethasone
metastasis
neutrophil count
liver metastasis
adenocarcinoma
antiretroviral therapy
systemic chemotherapy
metastatic adenocarcinoma
immunodeficiency
colorectal adenocarcinoma
hepatitis c
cholangiocarcinoma
hepatic arterial infusion
floxuridine
colorectal cancer

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.

Details
Condition Bile duct carcinoma, Colorectal Cancer, Colorectal Cancer, Rectal disorder, Biliary neoplasm
Age 18years - 100years
Treatment 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
Clinical Study IdentifierNCT04276090
SponsorMichael J Cavnar, MD
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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dexamethasone
metastasis
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systemic chemotherapy
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immunodeficiency
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