Spots Global Cancer Trial Database for Efficacy and Safety of Bevacizumab (Avastin®) Combined to Weekly Paclitaxel Followed by Bevacizumab (Avastin®) Alone in Patients With Relapsed Ovarian Sex-cord Stromal Tumours (ALIENOR)
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Trial Identification
Brief Title: Efficacy and Safety of Bevacizumab (Avastin®) Combined to Weekly Paclitaxel Followed by Bevacizumab (Avastin®) Alone in Patients With Relapsed Ovarian Sex-cord Stromal Tumours (ALIENOR)
Official Title: A Randomized, Open Label, Phase II Trial of Bevacizumab Plus Weekly Paclitaxel Followed by Bevacizumab Monotherapy Maintenance Versus Weekly Paclitaxel Followed by Observation in Patients With Relapsed Ovarian Sex-cord Stromal Tumours
Study ID: NCT01770301
Conditions
Study Description
Brief Summary: Bevacizumab (called also Avastin ®) is a medicine preventing the creation of new blood vessels (a process called "angiogenesis"). This can reduce blood flow of the tumor and then decreasing the contribution of nutriments and oxygen to the cancer cells and prevent the tumor from growing. In various types of cancers, as lung, breast, colorectal and renal cancer, addition of the bevacizumab to chemotherapy allowed to improve the disease outcome. The bevacizumab already benefits from a marketing authorization (MMA) for these various types of cancers. The bevacizumab has also obtained MMA for the treatment of the ovarian cancer in its most frequent histological form (ovarian carcinoma). Clinical trials conducted in this indication demonstrated the importance to pursue the treatment by bevacizumab after the chemotherapy is ended. This anti-angiogenic medicine is thought to be of a potential interest in sex cords- stromal since this tumors are very well vascularized. The ALIENOR study aims to explore the interest and the clinical benefit of associating bevacizumab to the paclitaxel in order to treat patients suffering from recurring sex cords- stromal tumor treated beforehand by platinum chemotherapy
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Hôpital Jean Minjoz, Besançon, , France
Institut Bergonié, Bordeaux, , France
Polyclinique Bordeaux Nord, Bordeaux, , France
Centre François Baclesse, Caen, , France
Centre Jean Perrin, Clermont-Ferrand, , France
Centre Georges François Leclerc, Dijon, , France
Centre Oscar Lambret, Lille, , France
Centre Léon Bérard, Lyon, , France
Institut Paoli Calmettes, Marseille, , France
ICM Val d'Aurelle, Montpellier, , France
ORACLE - Centre d'Oncologie de Gentilly, Nancy, , France
Hôpital Privé du Confluent, Nantes, , France
Hôpital Cochin, Paris, , France
Groupe Hospitalier Diaconesses - Croix Saint-Simon, Paris, , France
Hôpital Tenon, Paris, , France
Centre CARIO - HPCA, Plérin, , France
CHU de Poitiers - Hôpital de la Milétrie, Poitiers, , France
Institut Jean Godinot, Reims, , France
Centre Henri Becquerel, Rouen, , France
ICO Centre René Gauducheau, Saint-Herblain, , France
Hôpitaux Universitaires de Strasbourg, Strasbourg, , France
Institut Claudius Regaud, Toulouse, , France
ICL Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy, , France
Gustave Roussy, Villejuif, , France
Contact Details
Name: Isabelle RAY-COQUARD, MD, PhD
Affiliation: Centre Léon Bérard, LYON, FRANCE
Role: PRINCIPAL_INVESTIGATOR
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