Study of Pegylated Liposomal Doxorubicin and Temsirolimus in Patients With Advanced Hepatocellular Cancer
|ClinicalTrials.gov Identifier: NCT01281943|
Recruitment Status : Withdrawn (Doxil Shortage)
First Posted : January 24, 2011
Last Update Posted : July 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Liver Neoplasms||Drug: Temsirolimus 25mg and Pegylated liposomal doxorubicin 25mg/m2||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Pegylated Liposomal Doxorubicin (Doxil®) and Temsirolimus (Torisel®) in Patients With Advanced Hepatocellular Cancer|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||July 2012|
|Estimated Study Completion Date :||May 2014|
Experimental: Temsirolimus and Pegylated Liposomal Doxorubicin
Temsirolimus 25mg andPegylated liposomal doxorubicin 25mg/m2
Drug: Temsirolimus 25mg and Pegylated liposomal doxorubicin 25mg/m2
Temsirolimus 25mg IV on days 1, 8, 15 and 22 of each 28 day cycle
Pegylated liposomal doxorubicin 25mg/m2 IV on day 1 of each 28 day cycle
- Progression free survival (PFS) [ Time Frame: 15 months ]To determine whether the progression free survival (PFS) rate in patients with advanced HCC using this combination regimen of pegylated liposomal doxorubicin and temsirolimus exceeds 5 months in the majority of treated patients, justifying the further development of this therapeutic regimen in this patient population.
- Toxicity and tolerability for this combination regimen [ Time Frame: 3 months ]To further characterize the toxicity profile and tolerability for this combination regimen
- Disease control rate, objective response rate, and overall survival. [ Time Frame: 15 months ]To determine the disease control rate (DCR), objective response rate (ORR), and overall survival (OS) of this combination regimen
- mTOR inhibition [ Time Frame: 3 days ]To determine whether S6 kinase is inhibited in peripheral blood mononuclear cells (PBMCs) as an indication of adequate mTOR inhibitor exposure.
- Pharmacogenomics [ Time Frame: 1 day ]To measure Poly(ADP-ribose) polymerase-1 (PARP-1) activity in PBMCs from the patients as an indication of adequate doxorubicin exposure54.
- Polymoprhism assessment [ Time Frame: 1 day ]To assess whether common polymorphisms in ABCB1 and CYP2B6 are associated with any changes in treatment response or survival55.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01281943
|Principal Investigator:||A. Craig Lockhart, M.D.||Washington University School of Medicine|