Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Gemcitabine as Adjuvant Treatment After Resection of Intrahepatic Cholangiocarcinoma
Conditions
Intrahepatic Cholangiocarcinoma - Peripheral Cholangiocarcinoma - Cholangiolar Carcinoma - Cholangiocellular Carcinoma) (ICC)
Conditions: official terms
Carcinoma - Cholangiocarcinoma - Liver Neoplasms
Conditions: Keywords
HEPATIC ARTERIAL INFUSION, FLOXURIDINE, DEXAMETHASONE, GEMCITABINE, Pump, 13-148
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Liver resection and placement of hepatic artery infusion pump Type: Procedure
Name: FLOXURIDINE Type: Drug
Name: DEXAMETHASONE Type: Drug
Name: GEMCITABINE Type: Drug
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- 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.

- 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.

- Preoperative laboratory values within 14 days of 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

Exclusion Criteria:

- 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
Locations
Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, United States
Status: Recruiting
Contact: Andrea Cercek, MD - 646-888-4189
Memorial Sloan-Kettering Cancer Center at Commack
Commack, New York, United States
Status: Recruiting
Contact: Andrea Cercek, MD
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Andrea Cercek, MD - 646-888-4189
Memorial Sloan Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, United States
Status: Recruiting
Contact: Andrea Cercek, MD - 646-888-4189
Memorial Sloan Kettering Cancer Center Sleepy Hollow
Sleepy Hollow, New York, United States
Status: Recruiting
Contact: Andrea Cercek, MD - 646-888-4189
Start Date
September 2013
Sponsors
Memorial Sloan Kettering Cancer Center
Source
Memorial Sloan Kettering Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page