Primary objective: To evaluate the response rate of biweekly gemcitabine and oxaliplatin (the GEMOX regimen) in the first line treatment of metastatic or recurrent nasopharyngeal carcinoma. Secondary objectives: To assess the toxicity, duration of response, time to progression, progression-free survival, overall survival and cancer-related symptoms in the first line treatment of patients with metastatic or recurrent NPC.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
1000mg/m² over 10mg/m²/min
100 mg/m² over 2 hours.
Sanofi-Aventis Administrative Office
Hong Kong, Hong Kong
Efficacy: Tumor response rate based on Response Evaluation Criteria in Solid Tumour (RECIST) criteria
Time frame: Baseline to end of study
Safety: Clinical and laboratory criteria
Time frame: Baseline to end of study
The incidence of adverse events based on National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0
Time frame: Baseline to 30 days post treatment
Occurrence of serious adverse events (SAE)
Time frame: Baseline to 30 days post treatment
Drop-out rate
Time frame: End of study
Toxicity, duration of response, time to progression, progression-free survival, overall survival and cancer-related symptoms.
Time frame: Baseline to end of study
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