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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 currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01938729
First received: September 5, 2013
Last updated: July 16, 2014
Last verified: July 2014
  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. 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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    we will evaluate the recurrence-free survival of patients in this trial using Kaplan-Meier methods.


Estimated Enrollment: 28
Study Start Date: September 2013
Estimated Primary Completion Date: September 2017 (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.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/m2 Day 1 and 15 and HAI FUDR/Dex 0.12mg/kg/day Day 1-14 Level 2.Systemic gemcitabine 800mg/m2 Day 1 and 15 HAI FUDR/Dex 0.12 mg/kg/day Day 1-14 Level 3. Systemic gemcitabine 1000mg/m2 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  • Patients must have had a complete resection and hepatic artery pump placement
  • KPS ≥ 80%
  • Preoperative laboratory values within 14 days of registration must be:
  • Serum albumin must be >2.5 g/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
  • Preoperative laboratory values within 14 days of registration must be:
  • Bilirubin ≤ 1.5 mg/dl
  • 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
  • Patients that have concurrent malignancies (except localized basal cell or squamous cell skin cancers)
  • Female patients who are pregnant or lactating
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01938729

Contacts
Contact: Andrea Cercek, MD 646-888-4189
Contact: Michael D'Angelica, MD 212-639-3226

Locations
United States, New Jersey
Memorial Sloan-Kettering Cancer Center at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States
Contact: Andrea Cercek, MD    646-888-4189      
Contact: Michael D'Angelica, MD    212-639-3226      
Principal Investigator: Andrea Cercek, MD         
United States, New York
Memorial Sloan-Kettering Cancer Center at Commack Recruiting
Commack, New York, United States, 11725
Contact: Andrea Cercek, MD         
Principal Investigator: Andera Cercek, MD         
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Andrea Cercek, MD    646-888-4189      
Contact: Michael D'Angelica, MD    212-639-3226      
Principal Investigator: Andrea Cercek, MD         
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center Recruiting
Rockville Centre, New York, United States, 11570
Contact: Andrea Cercek, MD    646-888-4189      
Memorial Sloan-Kettering Cancer Center Sleepy Hollow Recruiting
Sleepy Hollow, New York, United States, 10591
Contact: Andrea Cercek, MD    646-888-4189      
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:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01938729     History of Changes
Other Study ID Numbers: 13-148
Study First Received: September 5, 2013
Last Updated: July 16, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Carcinoma
Cholangiocarcinoma
Liver Neoplasms
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Floxuridine
Gemcitabine
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antiviral Agents
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on November 27, 2014