A Study of the Safety and Effectiveness of Trabectedin for the Treatment of Localized Myxoid / Round Liposarcoma

• 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 ]

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.

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.

• Drug: Trabectedin
  Trabectedin 1.5 mg/m2 administered as a 24-hour iv infusion every 3 weeks for up to 18 weeks
• Drug: Dexamethasone
  Dexamethasone 20mg iv will be administered within 30 minutes before start of each trabectedin iv infusion

Inclusion Criteria:

• Diagnosis of myxoid / round cell liposarcoma (MRCL) and availability of pathology specimens for central review and pharmacogenomic studies
• Clinical evidence of locally advanced (Stage III), non-metastatic tumor, including locally recurring disease after initial surgery
• Measurable disease
• No prior chemotherapy or radiation (except for adjuvant post-operative radiotherapy)

Exclusion Criteria:

• Known hypersensitivity to any of the components of the trabectedin
• Pregnant or lactating women or men and women of reproductive potential who are not using effective contraceptive methods
• History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 5 years or longer
• Known distant metastases
• Other serious illnesses such as congestive heart failure or angina pectoris, myocardial infarction within 1 year before enrollment, uncontrolled arterial hypertension or arrhythmias