Neoplasms

Digestive System Diseases

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Pancreatic Neoplasms

Gastrointestinal Neoplasms

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Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Gemcitabine

Cisplatin

Pancrelipase

Sorafenib

Pancreatin

Protein Kinase Inhibitors

Enzyme Inhibitors

Sorafenib 400 mg po bid, continuously

Gemcitabine 1000 mg/m2, Cisplatin 25 mg/m2 day 1, and 8 every 21 days.

Gemcitabine 1000 mg/m2, Cisplatin 25 mg/m2 day 1, and 8 every 21 days

NEXAVAR\*112CPR RIV 200MG

Titolare AIC:

BAYER SpA

Numero di AIC dell'IMP:

037154010

Sorafenib 400 mg po bid, continuously

Gemcitabina 1000 mg/mq, Cisplatino 25 mg/mq day 1 and 8 every 21 days

Gemcitabina, Cisplatino

Stefano Cascinu, MProfessor

Silvia Rota, Data Manager

sandro Barni, MD

Alberto Sobrero, MD

Paolo Foa, MD

Gianfranco Pancera, MD

Donata Tabiadon, MD

Paolo Bidoli, MD

Stefano Cascinu, M.Pr

Roberto Labianca, MD

Francesco Di Costanzo, MD

Enrico Aitini, MD

Salvatore Siena, MPr

Stefano Cascinu, M.Professor

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.

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.

Metastatic Advanced Pancreas Sorafenib

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

Mario Negri Institute for Pharmacological Research

Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

Stefano CASCINU, Medical Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Metastatic Advanced Pancreas Sorafenib	NCT00758381	Locally Advance...	Sorafenib 400 m... Gemcitabina, Ci...	18 Years - 75 Years	Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Metastatic Advanced Pancreas Sorafenib	NCT00758381	Locally Advance...	Sorafenib 400 m... Gemcitabina, Ci...	18 Years - 75 Years	Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Metastatic Advanced Pancreas Sorafenib	NCT00758381	Locally Advance...	Sorafenib 400 m... Gemcitabina, Ci...	18 Years - 75 Years	Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

Spots Global Cancer Trial Database for sorafenib 400 mg po bid, continuously