CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
temsirolimus plus liposomal doxorubicindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00949325
NCT00949325Phase 2Completed
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Phase I/II Trial of Torisel and Liposomal Doxorubicin in Patients With Advanced Soft Tissue and Bone Sarcomas

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Jul 30, 2009·Updated Mar 11, 2019

In Brief

A Phase 2 clinical trial evaluating temsirolimus plus liposomal doxorubicin for Sarcoma. Completed, enrolled 24 participants across 1 site.

Detailed Summary

The purpose of this study is to identify a safe dosing regimen for the combination of Torisel and liposomal doxorubicin in patients with recurrent sarcoma. A secondary purpose of the study is to determine how effective this combination is for the treatment of recurrent sarcoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSarcoma
CountriesUnited States
CollaboratorsNational Comprehensive Cancer Network, Wyeth is now a wholly owned subsidiary of Pfizer

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 30, 2009
Enrollment StartSep 1, 2009
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 16.9 years ago

Interventions

temsirolimus plus liposomal doxorubicindrug

Patients were treated with temsirolimus (Torisel) weekly by IV and with liposomal doxorubicin (Doxil) (standard dose) by IV once every 28 days. Cohorts of patients receive sequentially increasing dose of temsirolimus until dose limiting toxicity (DLT) occurred and the maximally tolerated dose (MTD) was identified. The MTD dose was the standard dose of temsirolimus used for the remainder of the study. Dose modifications were based on protocol parameters for toxicities.