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

NCT01938729 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-09-11

No results posted yet for this study

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.

Conditions

  • Intrahepatic Cholangiocarcinoma
  • Peripheral Cholangiocarcinoma
  • Cholangiolar Carcinoma
  • Cholangiocellular Carcinoma) (ICC)

Interventions

PROCEDURE

Liver resection and placement of hepatic artery infusion pump

DRUG

FLOXURIDINE

DRUG

DEXAMETHASONE

DRUG

GEMCITABINE

Sponsors & Collaborators

  • Ohio State University

    collaborator OTHER

  • University of Texas Southwestern Medical Center

    collaborator OTHER

  • Washington University School of Medicine

    collaborator OTHER

  • Memorial Sloan Kettering Cancer Center

    lead OTHER

Principal Investigators

  • Andrea Cercek, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-05
Primary Completion
2020-09-10
Completion
2020-09-10

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01938729 on ClinicalTrials.gov