Hepatic Artery Infusion Pump for NPC Liver Metastases

• Status: Completed
• Trial end date: 2017-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiangya Hospital of Central South University
• Treatments: Dexamethasone; Floxuridine; Gemcitabine

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