The aim of the study is to assess if gemcitabine in combination with carboplatin as 1st line chemotherapy in patients with metastatic or recurrent nasopharyngeal carcinoma has reasonable efficacy and a favourable toxicity profile that warrants further comparative study. A parallel group of randomly selected patients of equal number to the carboplatin and gemcitabine combination arm will be treated with the cisplatin and 5-FU combination chemotherapy (active control arm). The hypothesis is that this combination of chemotherapy is at least as active and less toxic than the reference regimen of cisplatin in combination with 5-fluorouracil (5-FU).
52 patients with metastatic or recurrent nasopharyngeal carcinoma who meet inclusion/exclusion criteria will be enrolled into the trial. After initial screening, patients will attend clinic for baseline examination. Subjects will then be randomly allocated to carboplatin and gemcitabine or cisplatin and 5-FU combinations in a ratio of 1:1. Study visits will occur depending on which arm the patient is on. An economic evaluation of the costs and benefits of gemcitabine-carboplatin will be implemented within this protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Intravenous administration on days 1, 8 of a 21-day cycle
Intravenous following Gemcitabine infusion on day 1
Intravenous on day 1 prior to 5-FU infusion on days 2 to 5 of a 28-day cycle
Intravenous infusion on day 2 to day 5
Loh Guan Lye Specialist Centre
George Town, Malaysia
Penang General Hospital
George Town, Malaysia
Ipoh Specialist Centre
Ipoh, Malaysia
Johor Specialist Centre
Johor Bahru, Malaysia
NCI Cancer Hospital
Kampung Baharu Nilai, Malaysia
Likas Hospital
Kampung Likas, Malaysia
Sabah Medical Centre
Kota Kinabalu, Malaysia
Tung Shin Hospital
Kuala Lumpur, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Hospital Universiti Sains Malaysia
Kubang Kerian, Malaysia
...and 1 more locations
The primary efficacy variable is response to therapy. Response will be evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.
Time frame: 12 months
Progression free survival defined as the duration of time from start of treatment to time of disease progression or death, whichever occurs first.
Time frame: 12 months
Duration of response defined as the interval between the first documented response (CR or PR) and the first documented sign of disease progression or death, whichever occurs first.
Time frame: 12 months
Safety and tolerability assessments will consist of 1.Monitoring and recording all AE and SAE, 2.Regular monitoring of hematology, blood chemistry and urinary laboratory parameters, 3.Regular performance of physical examinations, including vital signs
Time frame: 12 months
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