Study of Erlotinib in Combination With Bortezomib
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 Velcade (bortezomib). 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 Bortezomib in Subjects With Advanced Cancer. Companion Study to Umbrella Protocol 2007-0638.|
- Tumor Response [ Time Frame: Evaluation of response after two 21-day cycles of treatment ] [ Designated as safety issue: Yes ]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 the tumor density, as measured in Hounsfield units (HU), by more than or equal to 15%.
- Maximum Tolerated Dose (MTD) [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]MTD defined as highest dose studied in which incidence of dose limiting toxicity (DLT) was less than 33%. DLT defined as any Grade 3 or 4 non-hematologic toxicity defined in the 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 the therapy.
|Study Start Date:||April 2009|
|Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Experimental: Erlotinib + Bortezomib
Up to 4 dose levels of study drug combination tested with 3-6 participants enrolled at each dose level. Erlotinib beginning dose of 150 mg taken by mouth daily for 21-day cycle. Bortezomib beginning dose of 1. mg/m^2 by vein over about 1-5 minutes on Days 1, 4, 8, and 11 of each 21-day cycle.
Drug: Erlotinib Hydrochloride
Beginning dose of 150 mg taken by mouth daily for 21-day cycle.
Other Names:Drug: Bortezomib
Beginning dose of 1. mg/m^2 by vein over about 1-5 minutes on Days 1, 4, 8, and 11 of each 21-day cycle.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00895687
|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|