Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Treating Patients With Primary Liver Cancer That Cannot Be Removed By Surgery - Full Text View

Sponsors and Collaborators:	Wake Forest University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00310102

Purpose

RATIONALE: Drugs used in chemotherapy, such as floxuridine and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving floxuridine together with dexamethasone directly into the arteries around the tumor may kill more tumor cells.

PURPOSE: This phase II trial is studying how well hepatic arterial infusion with floxuridine and dexamethasone works in treating patients with primary liver cancer that cannot be removed by surgery.

Condition	Intervention	Phase
Liver Cancer	Drug: dexamethasone Drug: floxuridine Genetic: comparative genomic hybridization Genetic: cytogenetic analysis Procedure: conventional surgery	Phase II

MedlinePlus related topics: Cancer Liver Cancer Surgery

Drug Information available for: Dexamethasone Floxuridine Dexamethasone acetate Doxiproct plus Dexamethasone Sodium Phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study of Continuous Hepatic Arterial Infusion With Floxuridine (FUDR) and Dexamethasone (DEX) in Patients With Unresectable Primary Hepatic Malignancy

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Antitumor activity in terms of response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:

Correlation of the underlying liver pathology (normal vs cirrhotic) of the patients with tolerability and response to therapy [ Designated as safety issue: Yes ]
Exploratory analysis of tumor specimens [ Designated as safety issue: No ]

Estimated Enrollment:	35
Study Start Date:	September 2004

Detailed Description:

OBJECTIVES:

Primary

Assess the efficacy of continuous hepatic arterial infusion comprising floxuridine and dexamethasone in patients with unresectable primary hepatocellular carcinoma or intrahepatic cholangiocarcinoma.
Assess the tolerability of this therapy, stratified by degree of underlying hepatic parenchymal disease, as determined on liver biopsy, in these patients.

Secondary

Evaluate changes in tumor perfusion during treatment by dynamic MRI in patients treated with this regimen.
Correlate changes in tumor perfusion with radiographic tumor response in patients treated with this regimen.
Investigate molecular genetic changes associated with these tumors using comparative genomic hybridization and cDNA array from tumor and liver biopsy specimens obtained at the time of surgery.

OUTLINE: This is a multicenter study.

Patients undergo surgery comprising abdominal exploration, liver biopsy, and hepatic artery pump placement. Patients then receive hepatic arterial infusion comprising floxuridine and dexamethasone continuously on days 1-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Tissue biopsies obtained at the time of pump placement are examined for molecular genetic abnormalities by cDNA array and comparative genomic hybridization studies.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed hepatocellular carcinoma or intrahepatic cholangiocarcinoma (i.e., peripheral cholangiocarcinoma, cholangiolar carcinoma, or cholangiocellular carcinoma)
- Patients suspected of having mixed tumors allowed
- Patients with a liver mass that is radiographically consistent with hepatocellular carcinoma and a serum alpha fetoprotein (AFP) > 500 ng/dL do not require biopsy confirmation
- Disease must be confined to the liver
  - Less than 70% liver involvement by cancer
Radiographically measurable disease
Unresectable disease
No clinical or radiographic evidence of extrahepatic disease
Patients who have failed prior ablative therapy allowed
No clinical ascites

PATIENT CHARACTERISTICS:

Karnofsky performance status 60-100%
Albumin > 2.5 g/dL
WBC > 3,500/mm³
Platelet count > 100,000/mm³
Bilirubin < 1.8 mg/dL
INR < 1.5 in patients not on warfarin therapy
Patients must be considered candidates for general anesthesia and hepatic artery pump placement
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Patients with chronic hepatitis and/or cirrhosis allowed if Child-Pugh class A
No sclerosing cholangitis
No Gilbert's disease
No hepatic encephalopathy
No radiographic evidence of esophageal varices or history of variceal hemorrhage
No occlusion of the main portal vein or the right and left portal branches
No active infection
No other malignancy except localized basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior floxuridine
No prior external beam radiation therapy to the liver
Prior exploratory surgery resulting in diagnosis of unresectable disease allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310102

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021

Sponsors and Collaborators

Wake Forest University

National Cancer Institute (NCI)

Investigators

Study Chair:

Perry Shen, MD

Wake Forest University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000466324, CCCWFU-55104, CCCWFU-BG04-320, MSKCC-02120A
Study First Received:	March 29, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00310102 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult primary hepatocellular carcinoma
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer
adult primary cholangiocellular carcinoma

Study placed in the following topic categories:

Antimetabolites
Anti-Inflammatory Agents
Dexamethasone
Cholangiocarcinoma
Liver Diseases
Digestive System Neoplasms
Antineoplastic Agents, Hormonal
Carcinoma, Hepatocellular
Floxuridine
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

Antiemetics
Hormones
Glucocorticoids
Recurrence
Carcinoma
Liver Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Peripheral Nervous System Agents
Hepatocellular Carcinoma
Dexamethasone acetate

Additional relevant MeSH terms:

Dexamethasone
Anti-Inflammatory Agents
Antimetabolites
Liver Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Liver Neoplasms
Neoplasms by Site

Therapeutic Uses
Dexamethasone acetate
Digestive System Neoplasms
Antineoplastic Agents, Hormonal
Floxuridine
Gastrointestinal Agents
Glucocorticoids
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009