Doxil, Bevacizumab and Temsirolimus Trial
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Trial of Doxil, Bevacizumab and Temsirolimus|
- Maximum tolerated doses (MTDs) and Dose-limiting toxicities (DLTs) [ Time Frame: First cycle (21 days) ] [ Designated as safety issue: Yes ]MTD defined as dose level below dose at which 2 of 6 patients experience drug-related dose limiting toxicity (DLT) in first cycle. Dose limiting toxicity (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 the 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 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:||August 2008|
|Study Completion Date:||August 2016|
|Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Experimental: Doxil, Bevacizumab + Temsirolimus
Doxil day 1 of each 21 day cycle, beginning dose level 10 mg/m^2 by vein over 3 hours.
Bevacizumab day 1 of each 21 day cycle, beginning dose level 5 mg/kg by vein over 90 minutes.
Temsirolimus days 1, 8 & 15 of 21 Day Cycle, beginning dose level 12.5 mg by vein over 30 to 60 minutes.
Day 1 of each 21 day cycle, beginning dose level 10 mg/m^2 by vein over 3 hours.
Other Names:Drug: Bevacizumab
Day 1 of each 21 day cycle, beginning dose level 5 mg/kg by vein over 90 minutes.
Other Names:Drug: Temsirolimus
Days 1, 8 & 15 of 21 Day Cycle, beginning dose level 12.5 mg by vein over 30 to 60 minutes.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00761644
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Daniel Karp, MD||M.D. Anderson Cancer Center|