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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
NEXAVAR\*112CPR RIV 200MG Titolare AIC: BAYER SpA Numero di AIC dell'IMP: 037154010
Gemcitabina 1000 mg/mq, Cisplatino 25 mg/mq day 1 and 8 every 21 days
A.O. Universitaria Ospedali Riuniti Umberto I
Ancona, Ancona, Italy
RECRUITINGOspedali Riuniti, Largo Barozzi, 1
Progression Free Survival
Time frame: time from randomization date to date of local or regional relapse
- overall Response Rate (RECIST Criteria) - duration of response - overall survival time
Time frame: time from the day of randomization to the date of death from any cause
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Bergamo, Bergamo, Italy
A.O. Treviglio-Caravaggio, P.le Ospedale n1
Treviglio, Bergamo, Italy
RECRUITINGA.O.Policlinico S.Orsola Malpighi
Bologna, Bologna, Italy
ACTIVE_NOT_RECRUITINGOspedale S.Orsola Fatebenefratelli
Brescia, BS, Italy
ACTIVE_NOT_RECRUITINGA.O. Careggi-Università, Viale Pieraccini, 17
Florence, Firenze, Italy
RECRUITINGOspedale Galliera
Genova, Genova, Italy
ACTIVE_NOT_RECRUITINGA.O. Ospedale S.Martino
Genova, GE, Italy
RECRUITINGA.O. Carlo Poma - Via Albertoni, 1
Mantua, Mantova, Italy
RECRUITINGA.O. Cà Granda, Piazza Ospedale Maggiore, 3
Milan, Milano, Italy
RECRUITING...and 7 more locations