Hepatic Arterial Infusion in Treating Patients With Locally Advanced, Non-Metastatic Cholangiocarcinoma

• Status: Active, not recruiting
• Trial end date: 2022-06-27
• Target enrollment: 0
• Participant gender: All

Summary

This pilot clinical trial studies the safety and effectiveness of continuous hepatic arterial infusion (HAI) of floxuridine (FUDR) alone or in combination with other chemotherapeutic drugs in treating patients with locally advanced cholangiocarcinoma that cannot be removed by surgery. HAI is a method to deliver higher concentrations of FUDR more directly to liver tumors and reduces side effects. HAI alone or in combination with oxaliplatin and/or gemcitabine may significantly improve clinical outcomes of patients with locally advanced cholangiocarcinoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Floxuridine; Gemcitabine; Oxaliplatin

Criteria

Inclusion Criteria:

• Patient must have suspected intrahepatic or hilar cholangiocarcinoma with minimal extrahepatic disease. Diagnosis must be histologically or cytologically confirmed for continued treatment on study after pump placement.

• Patient must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan/MRI

• Patient must have disease that is unresectable or borderline resectable with < 70% liver involvement by cancer

• Patient must be >= 18 years old.

• Patient's Eastern Cooperative Oncology Group (ECOG) performance status must be =< 2 (Karnofsky >= 60%)

• Patient must have normal organ and marrow function as defined below:

• Absolute neutrophil count >= 1,500/mcL

• Platelets >= 75,000/mcL

• Total bilirubin =< 2 mg/dL

• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 5 X institutional upper limit of normal

• Creatinine <= institutional upper limit normal

• Patient must be able to understand and willing to sign a written informed consent document

Exclusion Criteria:

• Patients must not have had prior treatment with FUDR

• Patient must not be receiving any other investigational agents

• Patient must not have a diagnosis of Gilbert's disease

• Patient must not have a diagnosis of hepatic encephalopathy

• Patient must not have had prior external beam radiation to the liver

• Patient must not have a diagnosis of sclerosing cholangitis

• Patient must not have any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Patient must not be pregnant or breastfeeding