Metastatic Advanced Pancreas Sorafenib (MAPS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00758381|
Recruitment Status : Unknown
Verified October 2008 by Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente.
Recruitment status was: Recruiting
First Posted : September 25, 2008
Last Update Posted : October 10, 2008
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced Pancreatic Cancer||Drug: Sorafenib 400 mg po bid, continuously Drug: Gemcitabina, Cisplatino||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||August 2007|
|Estimated Primary Completion Date :||August 2008|
|Estimated Study Completion Date :||August 2009|
Sorafenib 400 mg po bid, continuously
Gemcitabine 1000 mg/m2, Cisplatin 25 mg/m2 day 1, and 8 every 21 days.
Drug: Sorafenib 400 mg po bid, continuously
NEXAVAR*112CPR RIV 200MG
Numero di AIC dell'IMP:
Active Comparator: B
Gemcitabine 1000 mg/m2, Cisplatin 25 mg/m2 day 1, and 8 every 21 days
Drug: Gemcitabina, Cisplatino
Gemcitabina 1000 mg/mq, Cisplatino 25 mg/mq day 1 and 8 every 21 days
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00758381
|Contact: Stefano Cascinu, MProfessor||+39 071 5964 ext firstname.lastname@example.org|
|Contact: Silvia Rota, Data Manager||+39 0331 email@example.com|
|Study Chair:||Stefano Cascinu, M.Professor||GISCAD Foundation|