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Study of Pegylated Liposomal Doxorubicin and Temsirolimus in Patients With Advanced Hepatocellular Cancer

Liver Neoplasms Clinical Trial

Official title:
Phase II Study of Pegylated Liposomal Doxorubicin (Doxil®) and Temsirolimus (Torisel®) in Patients With Advanced Hepatocellular Cancer

Clinical Trial Summary

This Phase II study will use the MTD from a previous Phase I study at the recommended dose for the combination regimen from the Phase I trial, Doxil 25mg/m2 IV Q 4 weeks and temsirolimus 25mg IV Q week.

Clinical Trial Description

This proposal aims to capitalize on the consensus recommendations of the NCI panel, the known antitumor activity of doxorubicin in HCC, and the as yet unpublished results of a recently completed Phase I clinical trial (WU HRPO# 07-0447, NCT00703170) combining pegylated liposomal doxorubicin (Doxil®) and temsirolimus (Torisel®) in patients with advanced solid tumors. In this Phase I study, twenty-two patients were enrolled and treated. The MTD and recommended Phase II dose for the combination regimen from this trial is is Doxil 25mg/m2 IV Q 4 weeks and temsirolimus 25mg IV Q week. During the conduct of this study two patients experienced confirmed partial responses (PR). One patient had heavily pretreated metastatic breast cancer and remained on the study for 6 months. The second patient with a PR had HCC that was previously treated with sorafenib. She remained on the study regimen for 14 months and tolerated this treatment well. Based on the tolerability of the drug combination and the observed anti-tumor activity in HCC, the current Phase II study in HCC is proposed. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01281943
Study type Interventional
Source Washington University School of Medicine
Contact
Status Withdrawn
Phase Phase 2
Start date June 2011
Completion date May 2014
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