The Primary Objective is to evaluate the progression-free survival (PFS). The secondary objectives are: * To compare the disease control rates of different doses of Docetaxel+Cisplatin as first-line treatment according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria; * To evaluate the overall response rate (ORR); * To evaluate the time to disease progression (TTP); * To evaluate the overall survival (OS); * To evaluate the toxicity.
The study consists in: * A first line treatment phase: participants receive 4 cycles of chemotherapy (each cycle contains 3 weeks) with either docetaxel (75 mg/m2) plus cisplatin (75 mg/m2) or docetaxel (60 mg/m2) plus cisplatin (75 mg/m2) , * A maintenance treatment phase: participants with disease control (complete response \[CR\], partial response \[PR\] or stable disease \[SD\]) after the initial treatment receive up to 6 cycles of chemotherapy with docetaxel (60 mg/m2) or best supportive care (BSC). * A follow-up period from the end of study treatment until participant death or end of study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
375
Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-hour IV
Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-3-hour IV
Any treatment including palliative radiotherapy for pain relief-but not chemotherapy - that is considered appropriate by the investigator
Sanofi-Aventis Administrative Office
Shanghai, China
Progression-free survival (PFS) during the maintenance treatment phase
Time frame: From 2nd randomization to progression or death of any cause (every 2 cycles (6 weeks) during study treatment, and then every 8 weeks during follow-up period)
Disease control rate (DCR) during the first line treatment phase
Time frame: Every 2 cycles (6 weeks)
Overall response rate (ORR) during the first line treatment phase
Time frame: Every 2 cycles (6 weeks)
Time to disease progression (TTP) during the maintenance treatment phase
Time frame: From 2nd randomization up to disease progression (every 2 cycles (6 weeks))
Overall survival (OS)
Time frame: From 1st randomization to death of any cause (every 2 cycles (6 weeks) during study treatment, and then every 8 weeks during follow-up period)
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