A Phase II Study of Continuous Hepatic Arterial Infusion With Floxuridine (FUDR) and Dexamethasone (DEX) in Patients With Unresectable Primary Hepatic Malignancy

• Status: Completed
• Trial end date: 2016-05-19
• Target enrollment: 0
• Participant gender: All

Summary

This phase II study aims to evaluate regional chemotherapy in patients with unresectable primary hepatic malignancy. Specifically, eligible patients with hepatocellular carcinoma and peripheral cholangiocarcinoma, considered unresectable after review by the Hepatobiliary Surgery service, will undergo hepatic artery pump placement and continuous infusion of FUDR. The protocol includes radiological and biological correlative studies.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: Wake Forest University
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Floxuridine

Criteria

Inclusion Criteria:

• Patients with a liver mass that is radiographically consistent with HCC and a serum alpha fetoprotein (AFP) > 500 ng/dl do not require biopsy confirmation of the diagnosis.

• Patients with HCC or ICC undergoing exploration for a possible curative resection but found to have unresectable disease confined to the liver will be eligible, provided that no intraoperative findings would exclude them and prior informed consent has been obtained (see below).

• There must be <70% liver involvement by cancer, and the disease must be considered unresectable.

• Patients who have failed ablative therapy will be eligible.

• Patients must have a KPS > 60% and be considered candidates for general anesthesia and hepatic artery pump placement.

• Patients with chronic hepatitis and/or cirrhosis are eligible

• Serum albumin must be >2.5 g/dl and total serum bilirubin must be <1.8 mg/dl based on preoperative laboratory values within 14 days of registration.

• WBC must be >3500 cells/mm3 and platelet count must be >100,000/mm3 based on preoperative laboratory values within 14 days of registration.

• The international normalized ratio (INR) must be less than 1.5 in patients not on coumadin therapy, based on preoperative laboratory values within 14 days of registration.

• Age >_ 18 years.

• Female patients cannot be pregnant or lactating.

• Patients must be able to understand and sign informed consent.

Exclusion Criteria:

• Patients who have received prior treatment with FUDR

• Patients who have had prior external beam radiation therapy to the liver.

• Patients who have a diagnosis of sclerosing cholangitis.

• Patients who have a diagnosis of Gilbert's disease.

• Patients who have clinical ascites

• Patients with hepatic encephalopathy

• Patients who have radiographic evidence of esophageal varices or history of variceal hemorrhage.

• Patients with occlusion of the main portal vein nor of the right and left portal branches Patients that have concurrent malignancies (except localized basal cell or squamous cell skin cancers). Patient with active infection. Female patients who are pregnant or lactating.