NCT00796120

An Efficacy and Safety Study of Trabectedin Versus Doxorubicin-Based Chemotherapy in Participants With Translocation-Related Sarcomas (TRS)

A Randomized, Multicenter, Phase III Trial of Trabectedin (Yondelis) Versus Doxorubicin-based Chemotherapy as First-Line Therapy in Patients With Translocation-Related Sarcomas (TRS)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of trabectedin compared to standard doxorubicin in participants with advanced translocation-related sarcomas (cancer of connective tissue cells) (TRS).

Detailed description

This is a randomized (study drug assigned by chance), multicenter (when more than one hospital or medical school team work on a medical research study), Phase 3 trial to evaluate the efficacy and safety of trabectedin as compared to standard doxorubicin in participants with advanced TRS. Participants will be randomized in a 1:1 ratio to either of the 2 treatment groups, that is, trabectedin or doxorubicin plus ifosfamide group. Participants in trabectedin group will receive trabectedin 1.5 milligram per square meter (mg/m\^2) given as a 24-hour continuous intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) every 3 weeks and in doxorubicin plus ifosfamide group participants will receive doxorubicin 60 or 75 mg/m\^2 intravenously every 3 weeks followed by ifosfamide 6 to 9 gram (g)/m\^2 every 3 weeks. Participants in either treatment arm will continue receiving therapy in the absence of progressive disease (PD) or intolerable side effects, until the participants' consent is withdrawn or the eligibility criteria for continuing treatment are no longer fulfilled, or when a concurrent condition precludes continuation of treatment. Efficacy will be assessed primarily by evaluating progression-free survival (PFS). Participants' safety will be monitored throughout the trial.

Conditions

• Sarcoma

Interventions

Type	Name	Description
DRUG	Trabectedin	Trabectedin 1.5 milligram per square meter (mg/m\^2) will be given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
DRUG	Doxorubicin	Doxorubicin 60 or 75 mg/m\^2 will be given intravenously every 3 weeks until disease progression.
DRUG	Ifosfamide	Ifosfamide 6 to 9 g/m\^2 will be given intravenously every 3 weeks until disease progression.

Timeline

• Start date: 2008-11-01
• Primary completion: 2012-08-01
• Completion: 2014-08-01
• First posted: 2008-11-24
• Last updated: 2015-12-10
• Results posted: 2014-09-16

Locations

21 sites across 5 countries: United States, France, Germany, Spain, United Kingdom