Hepatic Artery Infusion Pump for NPC Liver Metastases

Study Overview
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Brief Summary
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A retrospective clinical trial to study the safety and effectiveness of hepatic arterial infusion (HAI) in treating patients who have nasopharyngeal carcinoma metastatic to the liver. Hepatic-direction drug administration improves the control power for intra-hapatic lesions.

Detailed Description
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OBJECTIVES: I. Determine the safety and toxicity of hepatic arterial infusion with gemcitabine, floxuridine and dexamethasone in combination with standard treatment (radiotherapy and systemic chemotherapy) in patients with nasopharyngeal carcinoma metastases to liver. II. Determine the objective response of intrahepatic lesions of patients treated with this regimen. III. Determine the median survival time or overall survival time in patients treated with this regimen. OUTLINE: This is a single-center retrospective study. Patients receive DSA-guided implantation of HAI catheter system. HAI is initiated the next day. Gemcitabine intra-arterially for 30 minutes on day 1,8, floxuridine, dexamethasone intra-arterially continuously on days 1-14. Treatment repeats every 3 weeks in the absence of serious technical catheter-related problems, progression of intrahepatic lesions or unacceptable toxicity. Standard treatment of NPC, including radiotherapy and chemotherapy (induction chemotherapy, concurrent chemotherapy and adjuvant chemotherapy) was performed as desired. Patients are followed every 2 HAI cycles or when necessary.

Official Title
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Hepatic Artery Infusion Gemcitabine and Floxuridine in Patients With Nasopharyngeal Carcinoma Liver Metastases

Conditions
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Nasopharyngeal Carcinoma, Neoplasm Metastasis, Liver

Intervention / Treatment
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* Procedure: DSA-guided implantation of hepatic artery infusion pump
* Drug: Gemcitabine
* Drug: Floxuridine
* Drug: dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed nasopharyngeal carcinoma with histologically confirmed or image diagnosed metastatic to the liver Standard treatment of NPC, including radiotherapy and chemotherapy (induction chemotherapy, concurrent chemotherapy and adjuvant chemotherapy) is performed as desired Performance status - ECOG 0-2 Absolute neutrophil count at least 1,200/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN No pre-existing chronic hepatic disease (chronic active hepatitis or cirrhosis) Creatinine no greater than ULN Creatinine clearance greater than 60 mL/min Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Adequate oral nutrition (at least 1,500 calories/day) Able to withstand major operative procedure No dehydration No severe anorexia No frequent nausea or vomiting No prior or concurrent malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of any organ No prior or concurrent malignancy associated with more than 10% probability of death from malignant disease within 5 years of diagnosis No concurrent immunotherapy No concurrent colony-stimulating factors during the first course of study therapy No more than 1 prior adjuvant systemic fluorouracil (5-FU) regimen with or without levamisole, leucovorin calcium, or irinotecan No prior hepatic artery infusion therapy with 5-FU or floxuridine No prior systemic chemotherapy for metastatic disease No prior or concurrent sorivudine or brivudine
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Patients undergo DSA-guided implantation of hepatic artery infusion pump. All patients receive the intervention Hepatic artery infusion of gemcitabine and floxuridine the next day after pump implantation. The HAI therapy is initiated on day 1, 8: Gemcitabine 1g/m2 for 30 minutes, followed by a blended solution which comprised floxuridine (FUDR) at 0.15 mg/kg/day, dexa-methasone (DXM) at 1 mg/m2/day, low molecular heparin 3200U and saline, lasted for 7 days continuously.Standard treatments of NPC, including radiotherapy and chemotherapy (induction chemotherapy, concurrent chemotherapy and adjuvant chemotherapy) are performed as desired. | Procedure: DSA-guided implantation of hepatic artery infusion pump<br>* Implant the infusion catheter and injection port (Celsite, B. Braun, Chasseneuil, France) under DSA-guiding. The proximal end of the infusion catheter was connected to the injection port and the device was implanted in a subcutaneous pocket in the right inner thigh; the distal end of the infusion catheter guarantee uni-direction infusion to liver.<br>Drug: Gemcitabine<br>* Given intra-arterially for 30 minutes<br>Drug: Floxuridine<br>* Given intra-arterially continuously for 14 days<br>* Other names: 5-FUDR;Drug: dexamethasone<br>* Given intra-arterially continuously with 5-FUDR<br>* Other names: DXM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate (DCR) of intrahepatic lesions | Assess the Disease control rate (DCR) of intrahepatic lesions by enhanced spiral-CT scan according to RECIST criteria. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival time | From the date of HAI catheter implantation to the date of death from any cause or to completion of trial, whichever comes first, up to 84 months. | 7 years | 
| Side effects and adverse events | To determine the safety and tolerability of HAI for NPC liver metastases by establishing the rates of toxicity | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatic artery infusion pump, Gemcitabine, Floxuridine