NCT00758381

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Advanced Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Sorafenib 400 mg po bid, continuously	NEXAVAR\*112CPR RIV 200MG Titolare AIC: BAYER SpA Numero di AIC dell'IMP: 037154010
DRUG	Gemcitabina, Cisplatino	Gemcitabina 1000 mg/mq, Cisplatino 25 mg/mq day 1 and 8 every 21 days

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-08-01
• Completion: 2009-08-01
• First posted: 2008-09-25
• Last updated: 2008-10-10

Locations

17 sites across 1 country: Italy