Hepatic Artery Infusion Pump for NPC Liver Metastases

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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

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.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Disease control rate (DCR) of intrahepatic lesions

Secondary Outcome

 Overall survival time

Condition

Nasopharyngeal Carcinoma

Intervention

DSA-guided implantation of hepatic artery infusion pump

Study Arms / Comparison Groups

 Treatment
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

16

Start Date

January 1, 2011

Completion Date

December 31, 2017

Primary Completion Date

December 31, 2017

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

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Administrative Informations

NCT ID

NCT03876574

Organization ID

NPC11330

Responsible Party

Sponsor

Study Sponsor

Xiangya Hospital of Central South University

Study Sponsor

, ,

Verification Date

February 2019