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Hepatic Artery Infusion Pump for NPC Liver Metastases

Primary Purpose

Nasopharyngeal Carcinoma, Neoplasm Metastasis, Liver

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

DSA-guided implantation of hepatic artery infusion pump

Gemcitabine

Floxuridine

dexamethasone

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Hepatic artery infusion pump, Gemcitabine, Floxuridine

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Side effects and adverse events

To determine the safety and tolerability of HAI for NPC liver metastases by establishing the rates of toxicity

Full Information

NCT ID

NCT03876574

First Posted

March 3, 2019

Last Updated

March 12, 2019

Sponsor

Xiangya Hospital of Central South University

1. Study Identification

Unique Protocol Identification Number

NCT03876574

Brief Title

Hepatic Artery Infusion Pump for NPC Liver Metastases

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

January 1, 2011 (Actual)

Primary Completion Date

December 31, 2017 (Actual)

Study Completion Date

December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xiangya Hospital of Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma, Neoplasm Metastasis, Liver

Keywords

Hepatic artery infusion pump, Gemcitabine, Floxuridine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

DSA-guided implantation of hepatic artery infusion pump

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Description

Given intra-arterially for 30 minutes

Intervention Type

Drug

Intervention Name(s)

Floxuridine

Other Intervention Name(s)

5-FUDR

Intervention Description

Given intra-arterially continuously for 14 days

Intervention Type

Drug

Intervention Name(s)

dexamethasone

Other Intervention Name(s)

DXM

Intervention Description

Given intra-arterially continuously with 5-FUDR

Primary Outcome Measure Information:

Title

Disease control rate (DCR) of intrahepatic lesions

Description

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Overall survival time

Description

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.

Time Frame

7 years

Title

Side effects and adverse events

Description

To determine the safety and tolerability of HAI for NPC liver metastases by establishing the rates of toxicity

Time Frame

2 years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

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Hepatic Artery Infusion Pump for NPC Liver Metastases

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