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

Intrahepatic Cholangiocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01938729
• Other study ID #: 13-148
• Status: Completed
• Phase: Phase 1
• Start date: September 5, 2013
• Est. completion date: September 10, 2020

Study information

• Verified date: September 2020
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 10, 2020
• Est. primary completion date: September 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Cholangiocarcinoma
• Cholangiocellular Carcinoma) (ICC)
• Cholangiolar Carcinoma
• Intrahepatic Cholangiocarcinoma
• Peripheral Cholangiocarcinoma

Intervention

Procedure:
• Liver resection and placement of hepatic artery infusion pump

Drug:
• FLOXURIDINE

• DEXAMETHASONE

• GEMCITABINE

Locations

Country	Name	City	State
United States	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

Sponsors (4)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Ohio State University, University of Texas Southwestern Medical Center, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Toxicity	All toxicities will be rated as per the NCI Common Toxicity Criteria (CTC AE version 4.0) except neurosensory and hepatic enzyme toxicities related to intrahepatic pump therapy.	1 year
Secondary	Recurrence Free Survival	we will evaluate the recurrence-free survival of patients in this trial using Kaplan-Meier methods.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center