Study of Erlotinib in Combination With Bortezomib
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|ClinicalTrials.gov Identifier: NCT00895687|
Recruitment Status : Completed
First Posted : May 8, 2009
Last Update Posted : July 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer||Drug: Erlotinib Hydrochloride Drug: Bortezomib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||July 2015|
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.
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.
- Tumor Response [ Time Frame: Evaluation of response after two 21-day cycles of treatment ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|