Clinical trial NCT01938729: Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Gemcitabine as Adjuvant Treatment After Resection of Intrahepatic Cholangiocarcinoma
Official title: Phase I Study of Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Gemcitabine as Adjuvant Treatment After Resection of Intrahepatic Cholangiocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Intrahepatic Cholangiocarcinoma
Peripheral Cholangiocarcinoma
Cholangiolar Carcinoma
Cholangiocellular Carcinoma) (ICC)
Keywords: HEPATIC ARTERIAL INFUSION
FLOXURIDINE
DEXAMETHASONE
GEMCITABINE
Pump
13-148
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Ohio State University
name: University of Texas Southwestern Medical Center
name: Washington University School of Medicine
First posted: 2013-09-10
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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 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

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

Primary outcomes:
measure: Safety and Toxicity
timeFrame: 1 year
Secondary outcomes:
measure: Recurrence Free Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center at Basking Ridge
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center at Commack
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Cancer Center at Mercy Medical Center
state: New York
city: Sleepy Hollow
country: United States
facility: Memorial Sloan Kettering Cancer Center Sleepy Hollow
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Andrea Cercek, MD
role: PRINCIPAL_INVESTIGATOR
References: