Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Gemcitabine as Adjuvant Treatment After Resection of Intrahepatic Cholangiocarcinoma
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.
|Intrahepatic Cholangiocarcinoma Peripheral Cholangiocarcinoma Cholangiolar Carcinoma Cholangiocellular Carcinoma) (ICC)||Procedure: Liver resection and placement of hepatic artery infusion pump Drug: FLOXURIDINE Drug: DEXAMETHASONE Drug: GEMCITABINE||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- Safety and Toxicity [ Time Frame: 1 year ]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.
- Recurrence Free Survival [ Time Frame: 1 year ]we will evaluate the recurrence-free survival of patients in this trial using Kaplan-Meier methods.
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||September 2018|
|Estimated Primary Completion Date:||September 2018 (Final data collection date for primary outcome measure)|
Experimental: HAI with FLOXURIDINE & DEXAMETHASONE & GEMCITABINE
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
|Procedure: Liver resection and placement of hepatic artery infusion pump Drug: FLOXURIDINE Drug: DEXAMETHASONE Drug: GEMCITABINE|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01938729
|United States, New Jersey|
|Memorial Sloan Kettering Cancer Center at Basking Ridge|
|Basking Ridge, New Jersey, United States|
|United States, New York|
|Memorial Sloan Kettering Cancer Center at Commack|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Memorial Sloan Kettering Cancer Center at Mercy Medical Center|
|Rockville Centre, New York, United States, 11570|
|Memorial Sloan Kettering Cancer Center Sleepy Hollow|
|Sleepy Hollow, New York, United States, 10591|
|Principal Investigator:||Andrea Cercek, MD||Memorial Sloan Kettering Cancer Center|