Spots Global Cancer Trial Database for Assessment of the Efficacy of Bevacizumab in Combination With Folfiri as Second-line Treatment in Patients Suffering From an Advanced Inoperable Poorly Differentiated Neuroendocrine Carcinoma of an Unknown or Gastroentero-pancreatic Primary Cancer
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Trial Identification
Brief Title: Assessment of the Efficacy of Bevacizumab in Combination With Folfiri as Second-line Treatment in Patients Suffering From an Advanced Inoperable Poorly Differentiated Neuroendocrine Carcinoma of an Unknown or Gastroentero-pancreatic Primary Cancer
Official Title: Assessment of the Efficacy of Bevacizumab in Combination With Folfiri as Second-line Treatment After the Failure of the Cisplatin (or Carboplatin)-Etoposide Combination in Patients Suffering From an Advanced Inoperable Poorly Differentiated Neuroendocrine Carcinoma of an Unknown or Gastroentero-pancreatic Primary Cancer. A Phase 2 Non-comparative Randomized Study
Study ID: NCT02820857
Conditions
Study Description
Brief Summary: Poorly differentiated neuroendocrine carcinomas (NEC) are a sub-group of aggressive neuroendocrine neoplasms (NEN). The most common primary sites are broncho-pulmonary and digestive. The gastroentero-pancreatic NECs (GEP-NEC) represent 7-21% of all of the NENs. Recent data on the initial presentation of GEP-NEC have been reported in two retrospective studies and a French cohort study. No standard second-line treatment has been defined for NECs. Despite a very negative prognosis, these NECs have a certain amount of chemosensitivity, close to that of bronchial NECs. Multiple-drug therapies such as Folfiri, or Folfox, or single drug treatments such as temozolomide are the proposed options but with a low level of proof Bevacizumab associated with a cytotoxic chemotherapy has shown promising results in well differentiated neuroendocrine tumors (NET), known for being hypervascular. The efficacy of bevacizumab has also been suggested in patients with NEC, but never in the context of a phase II study. Its combination with Folfiri is efficient and well tolerated in metastatic colorectal cancer. The combination Folfiri-bevacizumab potentially represents an optimized treatment compared to chemotherapy with only Folfiri. No phase II or III studies have reported results for these patients, and no on-going phase II or III trial have been identified to date. The main objective of this study is to show that, after the failure of a first-line chemotherapy using platinum-etoposide, the combination Folfiri-bevacizumab allows significant prolongation of overall survival in adult patients with GEP-NEC.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Service d'Hépato-Gastroenterologie et Oncologie Digestive, Hôpital Sud, CHU d'Amiens, Amiens, , France
Service d'Hépatogastroentérologie, CHU d'Angers, Angers, , France
Service d'Oncologie et Radiothérapie, Institut Sainte Catherine, Avignon, , France
Service de Gastroentérologie et Oncologie Digestive, Hôpital Avicenne, Bobigny, , France
Service de Gastroentérologie et Pancréatologie, Hôpital Beaujon, APHP, Clichy, , France
Service de Gastroentérologie, CHU Henri Mondor, Créteil, , France
Service d'Hépato-Gastroentérologie et Oncologie Digestive, CHU de Dijon, Dijon, , France
Service d'Hépatogastroentéologie, Hôpital Michallon, CHU de Grenoble, Grenoble, , France
Département de Cancérologie Urologique et Digestive, Centre Oscar Lambret, Lille, , France
Département de cancérologie médicale - Groupe des tumeurs endocrines, Centre Léon Bérard, Lyon, , France
Service d'Oncologie Médicale - Hôpital Edouard Herriot - Hospices Civils de Lyon, Lyon, , France
Département d'Oncologie Médicale, Institut Paoli Calmettes, Marseille, , France
Service d'Hépato-Gastroentérologie et d'Oncologie Digestive, Hôpital de la Timone, APHM, Marseille, , France
Service d'Oncologie Médicale, Hôpital Saint Eloi, CHU de Montpellier, Montpellier, , France
Service d'Hépatogastroentérologie, CHR d'Orléans, Orléans, , France
Département d'Oncologie Médicale, Hôpital Saint-Antoine, Paris, , France
Service de Gastroentérologie, Hôpital Cochin, APHP, Paris, , France
Service d'Hépato-Gastroenterologie et Oncologie Digestive, Hôpital Européen Georges Pompidou, APHP, Paris, , France
Service d'Hépato-Gastroentérologie et d'Oncologie Digestive, Hôpital Haut Lévêque, CHU Bordeaux, Pessac, , France
Pôle Régional de Cancérologie, CHU de Poitiers, Poitiers, , France
Service d'Hépato-Gastroentérologie et Cancérologie, Hôpital Robert Debré, CHU de Reims, Reims, , France
Service d'Hépatogastroentérologie, Hôpital Pontchaillou, CHU de Rennes, Rennes, , France
Service de Gastroentérologie, CHU de Rouen, Rouen, , France
Service de Gastro-Entérologie, Hôpital Nord, CHU de ST-Etienne, Saint-Priest-en-Jarez, , France
Service d'Oncologie Médicale, Hôpital Civil, CHU de Strasbourg, Strasbourg, , France
Service d'Oncologie Endocrinienne, Institut Gustave Roussy, Villejuif, , France
Contact Details
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