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Spots Global Cancer Trial Database for Study to Assess TOPO2A as a Biomarker for Sensitivity to Doxorubicin/Doxil in Soft Tissue Sarcoma

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Trial Identification

Brief Title: Study to Assess TOPO2A as a Biomarker for Sensitivity to Doxorubicin/Doxil in Soft Tissue Sarcoma

Official Title: A Study to Assess Topoisomerase II Alpha (TOPO2A) as a Biomarker for Sensitivity to Doxorubicin/Doxil in Soft Tissue Sarcoma

Study ID: NCT04055753

Interventions

Doxil
Doxorubicin

Study Description

Brief Summary: The primary aim of this study is to determine the utility of TOPO2A as a biomarker for sensitivity to doxorubicin or its derivatives. Patients whose planned therapy is doxorucibin or doxil single agent may be enrolled into this trial. In light of its recent FDA approval and differing mechanism of action, patients receiving olaratumab along with doxorubicin will be eligible for this study. Doxorucibin will be administered at standard 21-day intervals. Doxil will be administered at standard 28-day intervals. Response to therapy will be assessed using standard RECIST criteria every 2 cycles. Patients will continue on study until disease progression, prohibitive toxicity or completion of cumulative dose of 450 mg/m2 of either agent. Overall survival will be assessed every 3 months for 1 year, every 6 months in year 2 and, annually until death.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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