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Study to Assess TOPO2A as a Biomarker for Sensitivity to Doxorubicin/Doxil in Soft Tissue Sarcoma
Sponsor: Fox Chase Cancer Center
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.
Official title: A Study to Assess Topoisomerase II Alpha (TOPO2A) as a Biomarker for Sensitivity to Doxorubicin/Doxil in Soft Tissue Sarcoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
24
Start Date
2016-08-12
Completion Date
2027-10
Last Updated
2024-12-04
Healthy Volunteers
No
Conditions
Interventions
Doxil
Doxil 50 mg/m2, as per institutional standard
Doxorubicin
Doxorubicin 75 mg/m2, IV over 5-15 min OR Continuous infusion over 48-72 hours
Locations (1)
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States