Doxil, Bevacizumab and Temsirolimus Trial
The goal of this clinical research study is to learn the highest safe doses of the combination of Doxil (liposomal doxorubicin), Avastin (bevacizumab), and Torisel (Temsirolimus) that can be given to patients with advanced cancer that has spread or is unable to be surgically removed. The safety and effectiveness of this combination of drugs 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 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|
|Estimated 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
|Contact: Daniel Karp, MD||713-563-1930|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Daniel Karp, MD||M.D. Anderson Cancer Center|