Spots Global Cancer Trial Database for Activity of Trabectedin or Gemcitabine + Docetaxel in Uterine Leiomyosarcoma
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Trial Identification
Brief Title: Activity of Trabectedin or Gemcitabine + Docetaxel in Uterine Leiomyosarcoma
Official Title: A Phase II Randomized - Non Comparative - Study on the Activity of Trabectedin or Gemcitabine + Docetaxel in Metastatic or Locally Relapsed Uterine Leiomyosarcoma Pretreated With Conventional Chemotherapy
Study ID: NCT02249702
Conditions
Study Description
Brief Summary: The management of patients with uterine leiomyosarcomas poses many difficulties. Despite 60% of women present with disease limited to the uterus, cure rates range from 20 to 60%. Patients with metastatic disease at diagnosis or who recur after initial treatment have a dismal prognosis and, except for a subset of selected patients with completely resectable disease, the median survival is less than one year. Treatment options for recurrent/metastatic uterine leiomyosarcoma are limited. The most active drugs are doxorubicin ± ifosfamide and gemcitabine + docetaxel (GD) with response rate of 25-55% and 27-53%, respectively. Both these regimens have been increasingly used in the last years also in the adjuvant setting. For relapsed patients other drugs have been tested as single agent but negligible activity was observed. Trabectedin (Yondelis® -T) is a marine-derived cytotoxic approved by EMEA. It is indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide or who are unsuitable to receive these agents. Among STS, activity has been mainly detected in synovial sarcoma, liposarcoma and leiomyosarcoma. Although the response rate did not exceed 10%, T was demonstrated to provide disease control, with progression arrest rates exceeding 50% and progression-free survival rates exceeding 20% at 6 months. So far no phase II studies tested the activity of T in uterine leiomyosarcoma specifically. This study is aimed at evaluating the activity of T (arm A) in advanced uterine leiomyosarcomas, having GD (arm B) as an internal control In parallel translational studies will be performed to identify factors predictive of the activity of T in this specific histotype.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Centro di Riferimento Oncologico, Aviano, Pordenone, Italy
Policlinico Umberto I, Roma, RM, Italy
Fondazione del Piemonte per l'Oncologia, Candiolo, Turin, Italy
Azienda ULSS 13 Regione Veneto, Ospedale di Mirano, Mirano, Venice, Italy
Ospedale Sacro Cuore Don Calabria, Negrar, Verona, Italy
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo, Alessandria, , Italy
Azienda Ospedaliera Spedali Civili di Brescia, Brescia, , Italy
Presidio Ospedaliero Senatore Antonio Perrino, Brindisi, , Italy
Azienda Ospedaliera per l'Emergenza Cannizzaro, Catania, , Italy
Ospedale Sant'Anna, Como, , Italy
Azienda Ospedaliera S. Croce e Carle, Cuneo, , Italy
Azienda Ospedaliera Universitaria San Martino - IST, Genoa, , Italy
Ente Ospedaliero Ospedali Galliera, Genova, , Italy
Azienda USL 2 Toscana - Nuovo Ospedale San Luca, Lucca, , Italy
Istituto Nazionale dei Tumori di Milano, Milano, , Italy
Istituto Clinico Humanitas, Milan, , Italy
Istituto Europeo di Oncologia, Milan, , Italy
Istituto Nazionale dei Tumori di Milano, Milan, , Italy
Azienda Ospedaliera San Gerardo, Monza, , Italy
Istituto Nazionale Tumori - Fondazione Pascale, Napoli, , Italy
Azienda Ospedaliero Universitaria Maggiore della Carità, Novara, , Italy
Istituto Oncologico Veneto, Padova, , Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello, Palermo, , Italy
Azienda Ospedaliero-Universitaria di Parma, Parma, , Italy
Policlinico San Matteo, Pavia, , Italy
Azienda Ospadaliero-Universitaria Pisana, Pisa, , Italy
Azienda Ospedaliera Regionale San Carlo, Potenza, , Italy
Azienda Ospedaliera Arcispedale S. Maria Nuova, Reggio Emilia, , Italy
Ospedale San Giovanni Calibita Fatebenefratelli, Roma, , Italy
Policlinico Umberto I - Università Sapienza, Roma, , Italy
Policlinco Universitario Agostino Gemelli, Rome, , Italy
Azienda Ospedaliera Ordine Mauriziano, Torino, , Italy
Azienda Ospedaliero-Universitaria di Torino - Presidio Sant'Anna, Torino, , Italy
Presidio Sanitario Gradenigo, Torino, , Italy
Contact Details
Name: Angiolo Gadducci, MD
Affiliation: Azienda Ospedaliero Universitaria Pisana, Pisa, Italy
Role: PRINCIPAL_INVESTIGATOR
Name: Federica Grosso, MD
Affiliation: Azienda Ospedaliera Alessandria, Italy
Role: PRINCIPAL_INVESTIGATOR
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