Evaluating bevacizumab in combination with FOLFIRI after the failure of platinum-etoposide regimen in patients with advanced poorly differentiated neuroendocrine carcinoma: The PRODIGE 41–BEVANEC randomized phase II study

Thomas Walter, David Malka, Olivia Hentic, Catherine Lombard-Bohas, Karine Le Malicot, Denis Smith, Aurélie Ferru, Eric Assenat, Guillaume Cadiot, Astrid Lievre, Jean Emmanuel Kurtz, Laetitia Dahan, Olivier Dubreuil, Vincent Hautefeuille, Céline Lepere, Alice Gangloff, Farid Elhajbi, Romain Coriat, Guillaume Roquin, Nadia BouariouaVictoire Granger, Jean Yves Scoazec, Côme Lepage

Research output: Contribution to journalArticlepeer-review

18 Scopus citations

Abstract

Introduction: Patients with gastroenteropancreatic (GEP), metastatic or locally advanced, non-resectable, grade 3 poorly-differentiated neuroendocrine carcinoma (NEC) are treated with cisplatin (or carboplatin)-etoposide in first-line palliative chemotherapy (CT1). However, nearly all patients will develop resistance and there is no standard second-line treatment. Aim: PRODIGE 41–BEVANEC is an academic randomized, phase II study designed to evaluate the efficacy of bevacizumab in combination with FOLFIRI after failure of CT1 in unknown primary NEC and GEP-NEC. Materials and methods: The main eligibility criteria are age ≥18 years, metastatic (synchronous or metachronous) or locally advanced, non-resectable, grade 3 GEP-NEC, and documented progressive disease during or after CT1 therapy. Results: A total of 124 patients will be randomly assigned (1:1) to receive either 5 mg/kg bevacizumab with FOLFIRI, or FOLFIRI alone, every 14 days until disease progression or unacceptable toxicity. The hypothesis is to demonstrate a 6-month overall survival for at least 50% of the patients in bevacizumab arm versus 35% in the control arm (FOLFIRI alone). Secondary endpoints are objective response, response duration, progression-free survival, toxicity, and biochemical response. Conclusion: The study is currently opened in France (NCT02820857). The first patient was randomized on September 6, 2017.

Original languageEnglish
Pages (from-to)195-198
Number of pages4
JournalDigestive and Liver Disease
Volume50
Issue number2
DOIs
StatePublished - 1 Feb 2018
Externally publishedYes

Bibliographical note

Publisher Copyright:
© 2017 Editrice Gastroenterologica Italiana S.r.l.

Funding

Supported by Clinical Research Hospital Program grants ( PHRC 2014 ) from the French Ministry of Health ( PHRCK1470053N ). This study, sponsored by the Hospices Civils de Lyon, was authorized by the French medicines agency ANSM (Agence Nationale de Sécurité du Médicament et des produits de santé), number 170151A-12 on the 05/07/2017. It was submitted and approved (12/05/2017) by an institutional review board (Comité de protection des personnes).

FundersFunder number
French medicines agency ANSM
Ministère des Affaires Sociales et de la SantéPHRCK1470053N
Hospices civils de Lyon
Agence Nationale de Sécurité du Médicament et des Produits de Santé170151A-12

    Keywords

    • Bevacizumab
    • Clinical trial
    • FOLFIRI
    • Gastroenteropancreatic
    • Neuroendocrine carcinoma

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