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Spots Global Cancer Trial Database for Metastatic Advanced Pancreas Sorafenib

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Stefano Cascinu, M.Professor

Affiliation: GISCAD Foundation

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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