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) of Erlotinib in Combination with Cetuximab [ Time Frame: 28 days ] [ Designated as safety issue: No ]MTD defined by dose limiting toxicities (DLTs) that occur in the first cycle. DLT defined as any Grade 3 or 4 non-hematologic toxicity defined in NCI CTC v3.0, even if expected and believed related to study medications (except nausea and vomiting responsive to appropriate regimens or alopecia), any Grade 4 hematologic toxicity lasting 2 weeks or longer (as defined by the NCI-CTCAE), despite supportive care; any Grade 4 nausea or vomiting > 5 days despite maximum anti-nausea regimens, and any other Grade 3 non-hematologic toxicity, including symptoms/signs of vascular leak or cytokine release syndrome; or any severe or life-threatening complication or abnormality not defined in the NCI-CTCAE that is attributable to therapy.
- Patient Response Rate [ Time Frame: After two, 28-day cycles ] [ Designated as safety issue: No ]Tumor response defined as one or more of the following: (1) stable disease for more than or equal to 4 months, (2) decrease in measurable tumor (sentinel lesions) by more than or equal to 20% by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, (3) decrease in tumor markers by more than or equal to 25% (for example, a >/= 25% decrease in cancer antigen 125 (CA125) for patients with ovarian cancer), or (4) a partial response according to the Choi criteria, i.e. decrease in size by 10% or more, or a decrease in tumor density, as measured in Hounsfield units (HU), by more than or equal to 15%.
|Study Start Date:||April 2009|
|Primary Completion Date:||July 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00895362
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jennifer J. Wheler, MD||M.D. Anderson Cancer Center|