Status:
COMPLETED
Hepatic Artery Infusion Pump for NPC Liver Metastases
Lead Sponsor:
Xiangya Hospital of Central South University
Conditions:
Nasopharyngeal Carcinoma
Neoplasm Metastasis
Eligibility:
All Genders
Phase:
PHASE1
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-directio...
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 chemoth...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03876574
Start Date
January 1 2011
End Date
December 31 2017
Last Update
March 15 2019
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