Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Gemcitabine as Adjuvant Treatment After Resection of Intrahepatic Cholangiocarcinoma

Completed · Phase 1

Conditions studied: Intrahepatic Cholangiocarcinoma, Peripheral Cholangiocarcinoma, Cholangiolar Carcinoma, Cholangiocellular Carcinoma) (ICC)

In brief

This is a Phase I study, which means we want to find out what effects, good and/or bad, this combination of drugs may have on the patient and the liver cancer at different dose levels. All patients will have an operation to remove tumors in the liver and may have a pump placed in their abdomen. On this study, both drugs given have been used in other patients for treatment of cholangiocarcinoma and other gastrointestinal cancers. Both drugs are approved by the food and drug administration (FDA) for treatment of liver cancer, but the two drugs have only been combined in a few patients. That means that in this trial we also want to find out if this combination is safe. The study will also evaluate if this treatment works in delaying or stopping the cancer from coming back after surgery.

Key facts

Study ID: NCT01938729
Run by: Memorial Sloan Kettering Cancer Center
People needed: 8
Starts: 2013-09-05
Expected to finish: 2020-09-10
Last updated by the study team: 2020-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically confirmed intrahepatic cholangiocarcinoma (also variously reported as peripheral cholangiocarcinoma, cholangiolar carcinoma or cholangiocellular carcinoma) (ICC). Confirmation of the diagnosis must be made at MSKCC or at the participating institution prior to initiating protocol therapy.
Technically resectable, single tumors of any size, tumors with satellite nodules within 2 cm of the primary tumor that are resectable. Limited and resectable multi-focal disease (less than 4 tumors technically resectable).
Patients with elevated liver function tests including jaundiced patients (due to tumor) can be selectively operated on without resolution of jaundice preoperatively according to the judgment of the operating surgeon
Patients must have a KPS > 80% and be considered candidates for general anesthesia, hepatic resection and hepatic artery pump placement.
Laboratory values within 14 days before registration must be:
Serum albumin must be >2.5 g/dl
Creatinine must be < 1.8 mg/dL
WBC must be >3500 cells/mm3
Platelet count must be >100,000/mm3
International normalized ratio (INR) must be less than 1.5 in patients not on Coumadin therapy
Technically resectable, single tumors of any size, tumors with satellite nodules within 2 cm of the primary tumor that are resectable. Limited and resectable multi- focal disease (less than 4 tumors technically resectable).
Patients with elevated liver function tests including jaundiced patients (due to tumor) can be selectively operated on without resolution of jaundice preoperatively according to the judgment of the operating surgeon
Age >18 years
Patients must be able to understand and sign informed consent
Prior chemotherapy is allowed

You may not qualify if…

Prior treatment with HAI chemotherapy
Extrahepatic metastases including nodal disease
Prior external beam radiation therapy to the liver
Diagnosis of sclerosing cholangitis
Diagnosis of Gilbert's disease
Clinical ascites
Hepatic encephalopathy
Patients who have radiographic evidence of esophageal varices or history of variceal hemorrhage
Patients with occlusion of the main portal vein or of the right and left portal branches
Patients that have concurrent malignancies (except localized basal cell or squamous cell skin cancers)
Female patients who are pregnant or lactating

Where it is running

Memorial Sloan Kettering Cancer Center at Basking Ridge — Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Cancer Center at Commack — Commack, New York, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
Memorial Sloan Kettering Cancer Center at Mercy Medical Center — Rockville Centre, New York, United States
Memorial Sloan Kettering Cancer Center Sleepy Hollow — Sleepy Hollow, New York, United States

Full record on ClinicalTrials.gov

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