Doxil, Bevacizumab and Temsirolimus Trial
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|ClinicalTrials.gov Identifier: NCT00761644|
Recruitment Status : Completed
First Posted : September 29, 2008
Last Update Posted : April 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer||Drug: Doxil Drug: Bevacizumab Drug: Temsirolimus||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of Doxil, Bevacizumab and Temsirolimus|
|Actual Study Start Date :||August 21, 2008|
|Actual Primary Completion Date :||March 28, 2019|
|Actual Study Completion Date :||March 28, 2019|
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.
Day 1 of each 21 day cycle, beginning dose level 5 mg/kg by vein over 90 minutes.
Days 1, 8 & 15 of 21 Day Cycle, beginning dose level 12.5 mg by vein over 30 to 60 minutes.
- Maximum tolerated doses (MTDs) and Dose-limiting toxicities (DLTs) [ Time Frame: First cycle (21 days) ]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.
- Anti-Tumor Efficacy of Drug Combination [ Time Frame: 4 months ]Anti-tumor efficacy assessed by RECIST criteria.
- Anti-Tumor Efficacy of Drug Combination [ Time Frame: 4 months ]Anti-tumor efficacy assessed by WHO criteria.
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): 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|