Erlotinib in Combination With Cetuximab
|ClinicalTrials.gov Identifier: NCT00895362|
Recruitment Status : Completed
First Posted : May 8, 2009
Last Update Posted : July 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancers||Drug: Erlotinib Drug: Cetuximab||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||April 2009|
|Primary Completion Date :||July 2015|
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.
- Maximum Tolerated Dose (MTD) of Erlotinib in Combination with Cetuximab [ Time Frame: 28 days ]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 ]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%.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|