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Brief Title: Metastatic Advanced Pancreas Sorafenib
Official Title: A Randomized Phase II Study of Gemcitabine/Cisplatin With or Without Sorafenib to Evaluate the Efficacy and Safety in Patients With Locally Advanced or Metastatic Pancreatic Cancer. MAPS Trial
Study ID: NCT00758381
Brief Summary: This is multicentre, open-label, randomized, phase II trial in patients with locally advanced or metastatic pancreatic cancer. Subjects will be randomized in a 1:1 ratio to receive gemcitabine/cisplatin in combination with Sorafenib (arm A) or gemcitabine/cisplatin alone (arm B), as first-line chemotherapy.
Detailed Description: Up to date no standard treatment is available for pancreatic cancer. Although gemcitabine is commonly used in patients with pancreatic cancer with the purpose of symptom palliation, there is no clear evidence of efficacy in terms of survival increase or progression control. Furthermore, attempts at improving results by combining gemcitabine with other cytotoxic drugs failed to obtain any advantage. Recently, an EGFR inhibitor (erlotinib) showed a small survival advantage when combined with gemcitabine. results obtained with a combination of gemcitabine and oxaliplatin seem more promising. A meta-analysis of randomised trials comparing gemcitabine versus gemcitabine and platinum analogues showed a statistical significant survival advantage for the combination. Sorafenib is an inhibitor of the RAS/RAF signalling pathway. Furthermore, sorafenib is able to inhibit both VEGFR and PDGFR. Since RAS and RAF mutations are quite common in pancreatic cancer, Sorafenib could be useful in the management of these tumours. Furthermore, it may be combined with gemcitabine and cisplatin without any pharmacokinetic interaction or enhanced toxicity.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
A.O. Treviglio-Caravaggio, P.le Ospedale n1, Treviglio, Bergamo, Italy
Ospedale S.Orsola Fatebenefratelli, Brescia, BS, Italy
A.O. Ospedale S.Martino, Genova, GE, Italy
A.O. san Paolo, Milano, MI, Italy
Casa di Cura Igea, Milano, MI, Italy
Ospedale S.Carlo Borromeo, Milano, MI, Italy
A.O. S.Gerardo, Monza, MI, Italy
A.O. Universitaria Ospedali Riuniti Umberto I, Ancona, , Italy
Ospedali Riuniti, Largo Barozzi, 1, Bergamo, , Italy
A.O.Policlinico S.Orsola Malpighi, Bologna, , Italy
A.O. Careggi-Università, Viale Pieraccini, 17, Firenze, , Italy
Ospedale Galliera, Genova, , Italy
A.O. Carlo Poma - Via Albertoni, 1, Mantova, , Italy
A.O. Cà Granda, Piazza Ospedale Maggiore, 3, Milano, , Italy
Policlinico di modena, Modena, , Italy
Università Campus Biomedico, Via Emilio Longoni, 83, Roma, , Italy
A.O. S.Giovanni Calabita Fatebenefratelli, Roma, , Italy
Name: Stefano Cascinu, M.Professor
Affiliation: GISCAD Foundation
Role: STUDY_CHAIR