Hepatic Artery Infusion Pump for NPC Liver Metastases

Sponsor

Xiangya Hospital of Central South University (Other)

Overall Status

Completed

CT.gov ID

NCT03876574

Collaborator

(none)

Enrollment

Arm

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Carcinoma Neoplasm Metastasis Liver	Procedure: DSA-guided implantation of hepatic artery infusion pump Drug: Gemcitabine Drug: Floxuridine Drug: dexamethasone	Phase 1

Detailed Description

OBJECTIVES:

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.
Determine the objective response of intrahepatic lesions of patients treated with this regimen.
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Dec 31, 2017

Actual Study Completion Date :

Dec 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment 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 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. Drug: Gemcitabine Given intra-arterially for 30 minutes Drug: Floxuridine Given intra-arterially continuously for 14 days Other Names: 5-FUDR Drug: dexamethasone Given intra-arterially continuously with 5-FUDR Other Names: DXM

Arm

Intervention/Treatment

Experimental: Treatment

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

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.

Drug: Gemcitabine

Given intra-arterially for 30 minutes

Drug: Floxuridine

Given intra-arterially continuously for 14 days

Other Names:

5-FUDR

Drug: dexamethasone

Given intra-arterially continuously with 5-FUDR

Other Names:

DXM

Outcome Measures

Primary Outcome Measures

Disease control rate (DCR) of intrahepatic lesions [2 years]
Assess the Disease control rate (DCR) of intrahepatic lesions by enhanced spiral-CT scan according to RECIST criteria.

Secondary Outcome Measures

Overall survival time [7 years]
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.
Side effects and adverse events [2 years]
To determine the safety and tolerability of HAI for NPC liver metastases by establishing the rates of toxicity

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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