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Brief Title: Bevacizumab Beyond Progression in Platinum Sensitive Ovarian Cancer
Official Title: Multicenter Phase III Randomized Study With Second Line Chemotherapy Plus or Minus Bevacizumab in Patients With Platinum Sensitive Epithelial Ovarian Cancer Recurrence After a Bevacizumab/Chemotherapy First Line
Study ID: NCT01802749
Brief Summary: Bevacizumab has been found to prolong progression free survival in first line, and more recently, in second line treatment for platinum sensitive ovarian cancer patients who had not received prior treatment with bevacizumab. Recently reported data suggest that patients with colon cancer who receive bevacizumab in more than one line of therapy (beyond progression) have better results. In ovarian cancer, the role of bevacizumab administered in both first and second-line therapies needs to be defined. This study aims to evaluate whether administering bevacizumab in combination with chemotherapy in second-line therapy to patients with recurrent ovarian cancer who have received first-line bevacizumab will be more effective than chemotherapy alone.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Centre Hospitalier d'Aix-en-Provence, Aix-en-Provence, , France
Hôpital de la Côte Basque, Bayonne, , France
Institut Bergoniè, Bordeaux, , France
Hôpital Fleyriat, Bourg-en-Bresse, , France
Centre François Baclesse, Caen, , France
Centre Hospitalier Intercommunal de Créteil, Créteil, , France
Centre d'Oncologie et de Radiothérapie, Dijon, , France
Centre Georges Francois Leclerc, Dijon, , France
Centre Hospitalier du Mans, Le Mans, , France
Centre Hospitalier Universitaire Dupuytren, Limoges, , France
Centre Léon Bérard, Lyon, , France
Clinique de la Sauvegarde, Lyon, , France
Hôpital Nord, Marseille, , France
Hôpital Saint-Joseph, Marseille, , France
Clinique Claude Bernard, Metz, , France
Centre Azuréen de Cancérologie, Mougins, , France
Centre Hospitalier Général de Pau, Paris, , France
Hopital Cochin, Paris, , France
Hôpital des Diaconesses, Paris, , France
Hôpital Tenon, Paris, , France
Centre Hospitalier Général de Pau, Pau, , France
Centre Hospitalier de la Région d'Annecy, Pringy, , France
Institut Jean Godinot, Reims, , France
Hopital Renè Huguenin, Institut Curie, Saint Cloud, , France
Hôpital Inter Armées de Begin (HIA Begin),, Saint Mande, , France
GHPSO, Senlis, , France
Centre de Radiothèrapie - Clinique Sainte-Anne, Strasbourg, , France
Clinique des Dentellières,, Valenciennes, , France
Institut de Cancérologie Gustave Roussy, Villejuif, , France
Anticancer Hospital Agio Savvas, Athens, , Greece
General Hospital of Athens Alexandra, Athens, , Greece
General Oncology Hospital Agii Anargiri, Athens, , Greece
General Hospital of Thessaloniki Papageorgiou, Thessaloniki, , Greece
Centro di Riferimento Oncologico, Aviano, , Italy
A.O. G. Rummo, Benevento, , Italy
Spedali Civili Università di Brescia, Brescia, , Italy
Ospedale Senatore Antonio Perrino, Brindisi, , Italy
Fondazione del Piemonte per l'Oncologia IRCCS, Candiolo, , Italy
Osp. Cannizzaro, Catania, , Italy
Ospedale Civile di Faenza, Faenza, , Italy
I.R.C.C.S. San Martino IST, Genova, , Italy
Ospedale Galliera, Genova, , Italy
ASL 5 Spezzino Ospedale Felettino, La Spezia, , Italy
A.O. Vito Fazzi, Lecce, , Italy
Ospedale Manzoni di Lecco, Lecco, , Italy
Istituto Romagnolo per lo Studio e la Cura dei Tumori, Meldola, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
Istituto Nazionale Tumori, Milano, , Italy
U.L.S.S. 13, Mirano, , Italy
A.O.U. Federico II, Napoli, , Italy
A.O.U. Seconda Università di Napoli, Napoli, , Italy
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico, Napoli, , Italy
Ist. Sacro Cuore Don Calabria, Negrar, , Italy
NO AOU Maggiore della Carità, Novara, , Italy
Istituto Oncologico Veneto, Padova, , Italy
Casa di Cura La Maddalena, Palermo, , Italy
Osp Silvestrini, Perugia, , Italy
Ospedale Santa Chiara, Pisa, , Italy
A.O. S. Maria degli Angeli, Pordenone, , Italy
AO ASL 4, Prato, , Italy
Ospedale S. Maria delle Croci AUSL di Ravenna, Ravenna, , Italy
Arcispedale S. Maria Nuova, Reggio Emilia, , Italy
Ospedale Civile Rimini, Rimini, , Italy
Ospedale S. Giovanni Calibita Fatebenefratelli, Roma, , Italy
Policlinico Universitario Gemelli Università Cattolica del Sacro Cuore, Roma, , Italy
Policlinico Università Campus Biomedico, Roma, , Italy
Ospedale di Sondrio, Sondrio, , Italy
A.O. Ordine Mauriziano, Torino, , Italy
A.O. di Udine S. Maria della Misericordia, Udine, , Italy
Centre Hospitalier Princesse Grace, Monaco, , Monaco
Zentrum fùr Onkologie/ Hamat. und Transf, Aarau, , Switzerland
Universitatsspital,Frauenklinik, Basel, , Switzerland
IOSI, Bellinzona, , Switzerland
Klinik Engeried, Bern, , Switzerland
Kantonsspital, Chur, , Switzerland
Kantonsspital, Frauenfeld, , Switzerland
HUG Breast Center, Geneva, , Switzerland
Kantonsspital, Luzern, , Switzerland
Kantonsspital, Munsterlingen, , Switzerland
Kantonsspital, Olten, , Switzerland
Klinische Forschung Onkologie, St. Gallen, , Switzerland
Kantonsspital, Winterthur, , Switzerland
Name: Sandro Pignata, M.D., Ph.D.
Affiliation: National Cancer Institute, Naples
Role: PRINCIPAL_INVESTIGATOR
Name: Nicoletta Colombo, M.D.
Affiliation: European Institute of Oncology
Role: PRINCIPAL_INVESTIGATOR
Name: Francesco Perrone, M.D., Ph.D.
Affiliation: National Cancer Institute, Naples
Role: PRINCIPAL_INVESTIGATOR
Name: Gennaro Daniele, M.D., Ph.D.
Affiliation: National Cancer Institute, Naples
Role: PRINCIPAL_INVESTIGATOR
Name: Roldano Fossati, M.D.
Affiliation: Mario Negri Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Ciro Gallo, M.D.
Affiliation: University of Campania "Luigi Vanvitelli"
Role: PRINCIPAL_INVESTIGATOR
Name: Irene Floriani, Ph.D.
Affiliation: Mario Negri Institute
Role: PRINCIPAL_INVESTIGATOR