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Hepatic Artery Infusion Pump for NPC Liver Metastases

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ClinicalTrials.gov Identifier: NCT03876574
Recruitment Status : Completed
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Xiangya Hospital of Central South University

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:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
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 : January 1, 2011
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017


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 Name: 5-FUDR

Drug: dexamethasone
Given intra-arterially continuously with 5-FUDR
Other Name: DXM




Primary Outcome Measures :
  1. Disease control rate (DCR) of intrahepatic lesions [ Time Frame: 2 years ]
    Assess the Disease control rate (DCR) of intrahepatic lesions by enhanced spiral-CT scan according to RECIST criteria.


Secondary Outcome Measures :
  1. Overall survival time [ Time Frame: 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.

  2. Side effects and adverse events [ Time Frame: 2 years ]
    To determine the safety and tolerability of HAI for NPC liver metastases by establishing the rates of toxicity



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT03876574     History of Changes
Other Study ID Numbers: NPC11330
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiangya Hospital of Central South University:
Hepatic artery infusion pump
Gemcitabine
Floxuridine

Additional relevant MeSH terms:
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Carcinoma
Neoplasm Metastasis
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Dexamethasone
Gemcitabine
Floxuridine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal