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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01938729
First Posted: September 10, 2013
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ohio State University
University of Texas Southwestern Medical Center
Washington University School of Medicine
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
  Purpose

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.


Condition Intervention Phase
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 Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Recurrence Free Survival [ Time Frame: 1 year ]
    we will evaluate the recurrence-free survival of patients in this trial using Kaplan-Meier methods.


Enrollment: 8
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)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938729


Locations
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
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Ohio State University
University of Texas Southwestern Medical Center
Washington University School of Medicine
Investigators
Principal Investigator: Andrea Cercek, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01938729     History of Changes
Other Study ID Numbers: 13-148
First Submitted: September 5, 2013
First Posted: September 10, 2013
Last Update Posted: September 11, 2017
Last Verified: September 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:
HEPATIC ARTERIAL INFUSION
FLOXURIDINE
DEXAMETHASONE
GEMCITABINE
Pump
13-148

Additional relevant MeSH terms:
Carcinoma
Cholangiocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Dexamethasone acetate
Dexamethasone
Gemcitabine
Floxuridine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents