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

September 5, 2013
July 16, 2014
September 2013
September 2017   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01938729 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Gemcitabine as Adjuvant Treatment After Resection of Intrahepatic Cholangiocarcinoma
Phase I Study of 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. 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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
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

Interventions:
  • Procedure: Liver resection and placement of hepatic artery infusion pump
  • Drug: FLOXURIDINE
  • Drug: DEXAMETHASONE
  • Drug: GEMCITABINE
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
28
Not Provided
September 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Andrea Cercek, MD 646-888-4189
Contact: Michael D'Angelica, MD 212-639-3226
United States
 
NCT01938729
13-148
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • Ohio State University
  • University of Texas Southwestern Medical Center
  • Washington University School of Medicine
Principal Investigator: Andrea Cercek, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP