A Study of the Safety and Effectiveness of Trabectedin for the Treatment of Localized Myxoid / Round Liposarcoma
The purpose of this study is to determine the effects that trabectedin has on Myxoid / round cell liposarcoma (MRCL) when it is given before the tumor is removed by surgery.
Liposarcoma, Myxoid, Round Cell Component
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter Phase II Clinical Trial of Neoadjuvant Trabectedin (Yondelis) in Patients With Localized Myxoid / Round Cell Liposarcoma|
- Objective pathological complete response (CR) rate [ Time Frame: Up to approximately 18 months ] [ Designated as safety issue: No ]
- Objective tumor response by Response Evaluation Criteria In Solid Tumors (RECIST) [ Time Frame: Up to approximately 18 months ] [ Designated as safety issue: No ]
- The incidence of patients with adverse events [ Time Frame: Up to approximately 18 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2007|
|Study Completion Date:||January 2010|
Trabectedin 1.5 mg/m2 administered as a 24-hour iv infusion every 3 weeks for up to 18 weeks. Dexamethasone 20mg iv will be administered within 30 minutes before start of each trabectedin iv infusion.
Trabectedin 1.5 mg/m2 administered as a 24-hour iv infusion every 3 weeks for up to 18 weeksDrug: Dexamethasone
Dexamethasone 20mg iv will be administered within 30 minutes before start of each trabectedin iv infusion
Trabectedin will be administered 1.5 mg/m2 intravenously over 24 hours every three weeks. Patients will be assessed weekly by physical exam and / or laboratory testing. Radiological examination will occur every 6 weeks to evaluate the patient's disease. Patients participating in this study will undergo a surgery after the completion of the treatment in order to remove all the detectable disease and to find out if a pathologic complete response has occurred. Pathological complete response means that with surgery or biopsy no cancer is found. In this study, patients whose disease has not progressed at the end of the neoadjuvant treatment will be followed every 6 weeks until progression, 6 months post definitive surgery or until resolution of any drug-related adverse events (AEs) and sequelae. Trabectedin will be given at 1.5 mg/m2 over a 24-hour intravenous infusion every 3 weeks for a minimum of 3 and a maximum of 6 cycles of neoadjuvant trabectedin in the absence of overt disease progression, unmanageable toxicity, patient refusal or treatment delay longer than 3 weeks for toxicity (except in case of obvious patient benefit).Dexamethasone, 20mg, iv, will be administered within 30 minutes before start of each trabectedin iv infusion.
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|