Overview

This trial is active, not recruiting.

Conditions intrahepatic cholangiocarcinoma, peripheral cholangiocarcinoma, cholangiolar carcinoma, cholangiocellular carcinoma) (icc)
Treatments liver resection and placement of hepatic artery infusion pump, floxuridine, dexamethasone, gemcitabine
Phase phase 1
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator Ohio State University
Start date September 2013
End date September 2017
Trial size 8 participants
Trial identifier NCT01938729, 13-148

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
This is an open-label single arm study. multi-institution phase I dose escalating trial of adjuvant HAIP FUDR and Gemcitabine chemotherapy after curative resection of ICC. Hepatectomy with or without bile duct reconstruction and pump placement are performed. The patients will start therapy 4 weeks postoperatively. They will receive HAI FUDR/Dex and systemic gemcitabine in the following dose escalation levels of gemcitabine. The dose of HAI FUDR will be fixed. A classic 3+3 cohort dose escalation scheme will be used to identify the MTD of the combination. Level 1: Systemic gemcitabine 650mg/m^2 Day 1 and 15 and HAI FUDR/Dex 0.12mg/kg/day Day 1-14 Level 2.Systemic gemcitabine 800mg/m^2 Day 1 and 15 HAI FUDR/Dex 0.12 mg/kg/day Day 1-14 Level 3. Systemic gemcitabine 1000mg/m^2 Day 1 and 15 HAI FUDR/Dex 0.12 mg/kg/day Day 1-14
liver resection and placement of hepatic artery infusion pump
floxuridine
dexamethasone
gemcitabine

Primary Outcomes

Measure
Safety and Toxicity
time frame: 1 year

Secondary Outcomes

Measure
Recurrence Free Survival
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Andrea Cercek, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.
Location data was received from the National Cancer Institute and was last updated in September 2016.