Erlotinib in Combination With Cetuximab
The goal of this clinical research study is to find the highest tolerable dose of Tarceva (erlotinib hydrochloride) that can safely be given in combination with Erbitux (cetuximab). The safety of this drug combination will also be studied.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Dose-Escalation Study of Erlotinib in Combination With Cetuximab in Subjects With Advanced Cancer. Companion Study to Umbrella Protocol 2007-0638.|
- Maximum Tolerated Dose (MTD) [ Time Frame: With each 28 day cycle ] [ Designated as safety issue: Yes ]Continuous assessment of safety throughout entire study period and determination of MTD by dose-limiting toxicities during and at the end of 28 day cycle.
- Patient Response Rate [ Time Frame: Response evaluation every two 28-day cycles ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: Erlotinib + Cetuximab
Erlotinib in Combination with Cetuximab
Starting dose 100 mg by mouth 1 time every day for 28-day cycle (Pediatric starting dose 50 mg).
Other Names:Drug: Cetuximab
Loading dose of 200 mg/m^2 (maintenance 125 mg/m^2) by vein 1 day every week of 28-day cycle, on Days 1, 8, 15 and 22. First dose given over 2 hours and over 1 hour each subsequent time.
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|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jennifer J. Wheler, MD||UT MD Anderson Cancer Center|