A Phase II Study of Continuous Hepatic Arterial Infusion With Floxuridine (FUDR) and Dexamethasone (DEX) in Patients With Unresectable Primary Hepatic Malignancy

NCT00587067 | Completed Phase 2 Results

• 1 other identifier: 02-120
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II study aims to evaluate regional chemotherapy in patients with unresectable primary hepatic malignancy. Specifically, eligible patients with hepatocellular carcinoma and peripheral cholangiocarcinoma, considered unresectable after review by the Hepatobiliary Surgery service, will undergo hepatic artery pump placement and continuous infusion of FUDR. The protocol includes radiological and biological correlative studies.

Conditions

Hepatic Cancer

Keywords

FUDR; FLOXORUIDINE; DEXAMETHASONE; Hepatic; Cancer; 02-120

Outcome Measures

Primary Outcomes (2)

• Treatment Response

  To assess the efficacy of continuous arterial infusion (HAI) of FUDR (Floxuridine) and dexamethasone (DEX) in patients with unresectable hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC).

  Up to 5 years

• Number of Patients With Treatment Related Toxicity

  Toxicity evaluated and graded according to the National Cancer Institute, CTCAE v4.0

  Up to 5 years

Secondary Outcomes (2)

• Disease Progression

  Up to 5 years

• Median Survival

  Up to 5 years

Study Arms (1)

1

EXPERIMENTAL

Drug: FLOXURIDINE

Interventions

FLOXURIDINE DRUG

\[0.16\* mg/kg/day X 30 ml\] / pump flow rate \* If the patient is \>25% above ideal body weight, the dose of FUDR will be calculated from an average of the patients actual and ideal body weights. For example, for a patient who is 5ft. 10 inches and weighs 100kg: Ideal Body Weight (kg) = 50 + (2.3 X height in inches over 5 feet) = 50 + (2.3 X 10) = 73 Weight Used for dose calculation = (100 + 73)/2 = 86.5 Therefore, FUDR Dose will be = (0.16 X 86.5 X 30)/Flow Rate If no dose modification due to toxicity is required, the dosages given above (adjusted for changes in weight and pump flow rate) will be repeated on Day 1 of Week 1 of Cycle 2 and all subsequent cycles.

Also known as: FUDR

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a liver mass that is radiographically consistent with HCC and a serum alpha fetoprotein (AFP) \> 500 ng/dl do not require biopsy confirmation of the diagnosis.
• Patients with HCC or ICC undergoing exploration for a possible curative resection but found to have unresectable disease confined to the liver will be eligible, provided that no intraoperative findings would exclude them and prior informed consent has been obtained (see below).
• There must be \<70% liver involvement by cancer, and the disease must be considered unresectable.
• Patients who have failed ablative therapy will be eligible.
• Patients must have a KPS \> 60% and be considered candidates for general anesthesia and hepatic artery pump placement.
• Patients with chronic hepatitis and/or cirrhosis are eligible
• Serum albumin must be \>2.5 g/dl and total serum bilirubin must be \<1.8 mg/dl based on preoperative laboratory values within 14 days of registration.
• WBC must be \>3500 cells/mm3 and platelet count must be \>100,000/mm3 based on preoperative laboratory values within 14 days of registration.
• The international normalized ratio (INR) must be less than 1.5 in patients not on coumadin therapy, based on preoperative laboratory values within 14 days of registration.
• Age \>\_ 18 years.
• Female patients cannot be pregnant or lactating.
• Patients must be able to understand and sign informed consent.

You may not qualify if:

• Patients who have received prior treatment with FUDR
• Patients who have had prior external beam radiation therapy to the liver.
• Patients who have a diagnosis of sclerosing cholangitis.
• Patients who have a diagnosis of Gilbert's disease.
• Patients who have clinical ascites
• Patients with hepatic encephalopathy
• Patients who have radiographic evidence of esophageal varices or history of variceal hemorrhage.
• Patients with occlusion of the main portal vein nor of the right and left portal branches Patients that have concurrent malignancies (except localized basal cell or squamous cell skin cancers). Patient with active infection. Female patients who are pregnant or lactating.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Wake Forest University: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Liver Neoplasms; Neoplasms

Interventions

Floxuridine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Deoxyuridine; Uridine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Dr. William Jarnagin, MD
• Organization: Memorial Sloan Kettering Cancer Center

jarnagiw@mskcc.org

212-639-3624

Study Officials

• William Jarnagin, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 7, 2008
• Study Start: June 1, 2003
• Primary Completion: May 19, 2016
• Study Completion: May 19, 2016
• Last Updated: April 4, 2023
• Results First Posted: August 4, 2017

Record last verified: 2023-03

Locations

US (1)