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NCT Number: NCT01938729

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.

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Key information

Conditions

Intrahepatic Cholangiocarcinoma Adenocarcinoma Carcinoma Cholangiocarcinoma Cholangiocellular Carcinoma) (ICC) Cholangiolar Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Peripheral Cholangiocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan Kettering Cancer Center at Basking Ridge, Basking Ridge, New Jersey, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liver resection and placement of hepatic artery infusion pump

Procedure

FLOXURIDINE

Drug

Dexamethasone

Drug

Gemcitabine

Drug

Primary outcomes

  1. 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 outcomes

  1. Recurrence Free Survival

    Time frame: 1 year

    we will evaluate the recurrence-free survival of patients in this trial using Kaplan-Meier methods.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Ohio State University
  • University of Texas Southwestern Medical Center
  • Washington University School of Medicine

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2013
Registry last updated
Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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