drugset / Trial / NCT01189253

Doxorubicin Hydrochloride or Trabectedin in Treating Patients With Previously Untreated Advanced or Metastatic Soft Tissue Sarcoma

NCT01189253

RandomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride and trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether trabectedin is more effective than doxorubicin hydrochloride in treating patients with advanced or metastatic soft tissue sarcoma. PURPOSE: This randomized phase II/III trial is studying the safety of trabectedin compared with doxorubicin hydrochloride and to see how well they work in treating patients with advanced or metastatic soft tissue sarcoma.

Timeline

Start
2011-05
Primary completion
2013-06
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Doxorubicin Other / unclassified 75 mg/m2 Intravenous
Subject Trabectedin Small molecule 1.3 mg/m2 Intravenous
Subject Trabectedin Small molecule 1.5 mg/m2 Intravenous

Indications