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Brief Title: Trabectedin First Line Therapy In Unfit Sarcoma Study
Official Title: SAFETY AND ACTIVITY OF TRABECTEDIN AS FIRST LINE IN ADVANCED SOFT TISSUE SARCOMA (STS) PATIENTS UNFIT TO RECEIVE STANDARD CHEMOTHERAPY: A PROSPECTIVE PHASE II STUDY WITH CLINICAL AND MOLECULAR CORRELATES
Study ID: NCT02066675
Brief Summary: Phase II, non-randomized, two-stage study according to Bryant \& Day The study enroll patients with Metastatic and locally advanced soft tissue sarcoma unfit to receive standard chemotherapy (doxorubicin/epirubicin and/or ifosfamide)
Detailed Description: Soft tissue sarcomas are a group of rare and aggressive disease, comprising more than a hundred different histological subtypes and mainly originating from the embryonic mesoderm. Today, they represent less than 1% of all adult cancers, with an incidence of 3/100000/year and a median age at diagnosis of 65 years. Despite the progress done in the last decade, approximately 50% of STS patients still develop distant metastases within 3 years from the diagnosis and die from their disease. Doxorubicin (or epirubicin) and ifosfamide have been proved to be active in the treatment of STS and they are widely used, alone or in combination, as a first line therapy for locally advanced and metastatic patients. However, the response rate to the combination regimen in non-pretreated patients does not exceed 30-40%, and large randomized clinical trials failed to demonstrate any advantage in survival for the combination compared to single-agent treatment. Trabectedin (Yondelis®) is a marine-derived anticancer agent that has been approved in the European Union as a single agent for the treatment of STS patients after failure of standard chemotherapy (doxorubicin and/or ifosfamide) or for those unsuited to receive these agents. Even if the response rate in soft tissue sarcoma does not exceed 10%, trabectedin can provide a significant clinical benefit, by arresting disease progression in almost 50% of treated patients, with a progression-free survival rate of 20% at 6 months. Trabectedin was found to be particularly active in the treatment of myxoid liposarcoma and uterine leiomyosarcoma, for which better results have been obtained in terms of response rate and survival, suggesting an histotype driven activity. The toxicity profile of trabectedin given as second line therapy has been widely assessed in clinical studies and was largely manageable, with the majority of adverse events being grade 1 or 2 toxicities, generally reversible, dose or time dependent and noncumulative. The good tolerability profile observed in the trials seems to be confirmed also in everyday clinical practice. Conversely, few data are available at the moment about tolerability profile for those patients treated with trabectedin as first line because of medical conditions contraindicating the use of standard agents. The aim of this phase II study is to assess and describe trabectedin toxicity profile in this subset of negatively selected advanced inoperable STS patients.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Ospedali Riuniti di Bergamo, Bergamo, BG, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST, Meldola, FC, Italy
Ospedale Galliera, Genova, Genovs, Italy
IRCCS Azienda Ospedaliera Universitaria San Martino IST, Genova, GE, Italy
Ospedale Villa Scassi, Genova, GE, Italy
Ospedale Misericordia e Dolce" Istituto Toscano Tumori, Azienda USL4, Prato, PO, Italy
I.R.C.C. - Unit of Medical Oncology, Candiolo, Torino, Italy
Presidio Sanitario Gradenigo, Torino, TO, Italy
A.S.O. "SS Antonio e Biagio e Cesare Arrigo", Alessandria, , Italy
Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors, Bologna, , Italy
Ospedale SS. Trinità di Sora, Frosinone, , Italy
IST, Genova, , Italy
Policlinico Federico II Napoli, Napoli, , Italy
Istituto Oncologico Veneto, Padova, , Italy
Ospedale Giaccone, Palermo, , Italy
Campus Biomedico, Roma, , Italy
Name: Federica Grosso, MD
Affiliation: ASO SS Antonio e Biagio e C Arrigo Alessandria, Italy
Role: PRINCIPAL_INVESTIGATOR