Hepatic Artery Infusion Pump for NPC Liver Metastases

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03876574
• Other study ID #: NPC11330
• Status: Completed
• Phase: Phase 1
• Start date: January 1, 2011
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2019
• Source: Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Liver
• Nasopharyngeal Carcinoma
• Neoplasm Metastasis

Intervention

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
• Floxuridine
Given intra-arterially continuously for 14 days
• dexamethasone
Given intra-arterially continuously with 5-FUDR

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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