Metastatic Advanced Pancreas Sorafenib
MAPS
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
1 other identifier
interventional
114
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2007
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 22, 2008
CompletedFirst Posted
Study publicly available on registry
September 25, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedOctober 10, 2008
October 1, 2008
1 year
September 22, 2008
October 9, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
time from randomization date to date of local or regional relapse
Secondary Outcomes (1)
- overall Response Rate (RECIST Criteria) - duration of response - overall survival time
time from the day of randomization to the date of death from any cause
Study Arms (2)
A
EXPERIMENTALSorafenib 400 mg po bid, continuously Gemcitabine 1000 mg/m2, Cisplatin 25 mg/m2 day 1, and 8 every 21 days.
B
ACTIVE COMPARATORGemcitabine 1000 mg/m2, Cisplatin 25 mg/m2 day 1, and 8 every 21 days
Interventions
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
Eligibility Criteria
You may qualify if:
- Signed written informed consent prior to beginning protocol specific procedures
- Male or female 18 to 75 years of age
- Diagnosis of histologically confirmed adenocarcinoma of the pancreas
- Locally advanced (non-resectable) or metastatic pancreatic cancer
- Presence of at least one uni-dimensional indicator lesion measurable by CT scan or MRI in not an irradiated area (RECIST criteria)
- Karnofsky performance status of ≥ 70 at study entry
- Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 9 g/dL
- Bilirubin level either normal or \< 1.5 x ULN
- ASAT and ALAT ≤ 2.5 X ULN (≤ 5 x ULN if liver metastasis are present)
- Serum creatinine \< 1.5 x ULN
- Amylase and lipase ≤ 1.5 x the upper limit of normal
- PT or INR and PTT \< 1.5 x upper limit of normal (subjects who receive anti-coagulation treatment with an agent such as warfarin or heparin will be allowed to participate provided that no evidence of underlying abnormality in these parameters exists).
- Effective contraception for both male and female patients if the risk of conception exists
You may not qualify if:
- Brain metastases
- Previous chemotherapy for locally advanced or metastatic pancreatic cancer.
- Adjuvant therapy if documented recurrence is within 6 months after the end of adjuvant treatment)
- Radiotherapy within 4 weeks prior to study entry
- Major surgery within 4 weeks of first dose of study drug
- Concurrent chronic systemic immune therapy
- Any investigational agent(s) 4 weeks prior to entry
- Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 6 months
- Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months
- Acute or subacute intestinal occlusion or history of inflammatory bowel disease
- Known grade 3 or 4 allergic reaction to any of the components of the treatment
- Known drug abuse/ alcohol abuse
- Legal incapacity or limited legal capacity
- Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
- Women who are pregnant or breastfeeding
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
A.O. Universitaria Ospedali Riuniti Umberto I
Ancona, Ancona, 60020, Italy
Ospedali Riuniti, Largo Barozzi, 1
Bergamo, Bergamo, 24128, Italy
A.O. Treviglio-Caravaggio, P.le Ospedale n1
Treviglio, Bergamo, 24047, Italy
A.O.Policlinico S.Orsola Malpighi
Bologna, Bologna, 40138, Italy
Ospedale S.Orsola Fatebenefratelli
Brescia, BS, 15100, Italy
A.O. Careggi-Università, Viale Pieraccini, 17
Florence, Firenze, 50139, Italy
Ospedale Galliera
Genova, Genova, 16132, Italy
A.O. Ospedale S.Martino
Genova, GE, 16132, Italy
A.O. Carlo Poma - Via Albertoni, 1
Mantova, Mantova, 46100, Italy
A.O. Cà Granda, Piazza Ospedale Maggiore, 3
Milan, Milano, 20162, Italy
A.O. san Paolo
Milan, MI, 20100, Italy
Casa di Cura Igea
Milan, MI, 20100, Italy
Ospedale S.Carlo Borromeo
Milan, MI, 20123, Italy
A.O. S.Gerardo
Monza, MI, 20052, Italy
Policlinico di modena
Modena, Modena, 41100, Italy
Università Campus Biomedico, Via Emilio Longoni, 83
Roma, Roma, 00155, Italy
A.O. S.Giovanni Calabita Fatebenefratelli
Roma, Roma, 00186, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Stefano Cascinu, M.Professor
GISCAD Foundation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 22, 2008
First Posted
September 25, 2008
Study Start
August 1, 2007
Primary Completion
August 1, 2008
Study Completion
August 1, 2009
Last Updated
October 10, 2008
Record last verified: 2008-10