9
Participants
Start Date
September 30, 2009
Primary Completion Date
June 30, 2012
Study Completion Date
October 31, 2012
Temsirolimus
"Temsirolimus will be administered intravenously weekly on days one and eight of a three week cycle. Temsirolimus will not be given on week three (usually dosed weekly) for increased tolerability given its possible plasma accumulation during week three. Temsirolimus will be given second over a 30 minute infusion during posthydration.~Dose escalation will follow the standard 3 by 3 design with three set dosing levels.~Dose Level 1: Temsirolimus 15mg~Dose Level 2: Temsirolimus 15mg~Dose Level 3: Temsirolimus 25mg"
Cisplatin
Cisplatin at 30mg/m2 will be administered intravenously weekly on days one and eight of a three week cycle. Cisplatin will be given first over a 30 minute infusion with prehydration.
Erlotinib
"Erlotinib will be taken by mouth daily starting at 100mg. On days of cisplatin and temsirolimus infusions, erlotinib should be taken at least two hours after the beginning of the temsirolimus infusion.~Dose escalation will follow the standard 3 by 3 design with three set dosing levels.~Dose Level 1: Erlotinib 100mg~Dose Level 2: Erlotinib 150mg~Dose Level 3: Erlotinib 150mg"
Columbia University Medical Center, New York
Collaborators (1)
Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Genentech, Inc.
INDUSTRY
Columbia University
OTHER