Study of Pegylated Liposomal Doxorubicin and Temsirolimus in Patients With Advanced Hepatocellular Cancer
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|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Recruitment Status : Withdrawn (Doxil Shortage)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.
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): NCT01281943
|Principal Investigator:||A. Craig Lockhart, M.D.||Washington University School of Medicine|