drugset / Trial / NCT01189253
Doxorubicin Hydrochloride or Trabectedin in Treating Patients With Previously Untreated Advanced or Metastatic Soft Tissue Sarcoma
Phase 2/3
Terminated
133 enrolled
European Organisation for Research and Treatment of Cancer - EORTC
Sarcoma Alliance for Research through Collaboration · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |