Study of Temsirolimus, Erlotinib and Cisplatin in Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

June 30, 2012

Study Completion Date

October 31, 2012

Conditions
Triple Negative Breast Cancer
Interventions
DRUG

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"

DRUG

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.

DRUG

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"

Trial Locations (1)

10032

Columbia University Medical Center, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

collaborator

Genentech, Inc.

INDUSTRY

lead

Columbia University

OTHER