43
Participants
Start Date
November 30, 2004
Primary Completion Date
June 30, 2010
Study Completion Date
December 31, 2010
Docetaxel, Cisplatin and STI571
"Treatment will consist of docetaxel plus cisplatin IV every 21days and oral STI571 given on Days -5 to 2 with each chemotherapy cycle. A maximum of 6 cycles will be given.~Phase 1 dose levels are:~* Level 1 Docetaxel/Cisplatin 60 mg/m2, STI571 300mg~* Level 2 Docetaxel/Cisplatin 60 mg/m2, STI571 400mg~* Level 3 Docetaxel/Cisplatin 70 mg/m2, STI571 400mg~* Level 4 Docetaxel/Cisplatin 70 mg/m2, STI571 600mg~* Level 5 Docetaxel/Cisplatin 75 mg/m2, STI571 600mg~* Level 6 Docetaxel/Cisplatin 75 mg/m2, STI571 800mg~Once the MTD level has been established, the previous dose level will be the dosing schedule for Phase II."
Docetaxel
Cisplatin
Lead Sponsor
Duke University
OTHER