Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
114 participants
INTERVENTIONAL
2007-08-31
2009-08-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Sorafenib 400 mg po bid, continuously
Gemcitabine 1000 mg/m2, Cisplatin 25 mg/m2 day 1, and 8 every 21 days.
Sorafenib 400 mg po bid, continuously
NEXAVAR\*112CPR RIV 200MG
Titolare AIC:
BAYER SpA
Numero di AIC dell'IMP:
037154010
B
Gemcitabine 1000 mg/m2, Cisplatin 25 mg/m2 day 1, and 8 every 21 days
Gemcitabina, Cisplatino
Gemcitabina 1000 mg/mq, Cisplatino 25 mg/mq day 1 and 8 every 21 days
Interventions
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Sorafenib 400 mg po bid, continuously
NEXAVAR\*112CPR RIV 200MG
Titolare AIC:
BAYER SpA
Numero di AIC dell'IMP:
037154010
Gemcitabina, Cisplatino
Gemcitabina 1000 mg/mq, Cisplatino 25 mg/mq day 1 and 8 every 21 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Acute or subacute intestinal occlusion
* Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial).
18 Years
75 Years
ALL
No
Sponsors
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Mario Negri Institute for Pharmacological Research
OTHER
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
OTHER
Responsible Party
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Fondazione GISCAD
Principal Investigators
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Stefano Cascinu, M.Professor
Role: STUDY_CHAIR
GISCAD Foundation
Locations
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A.O. Universitaria Ospedali Riuniti Umberto I
Ancona, Ancona, Italy
Ospedali Riuniti, Largo Barozzi, 1
Bergamo, Bergamo, Italy
A.O. Treviglio-Caravaggio, P.le Ospedale n1
Treviglio, Bergamo, Italy
A.O.Policlinico S.Orsola Malpighi
Bologna, Bologna, Italy
Ospedale S.Orsola Fatebenefratelli
Brescia, BS, Italy
A.O. Careggi-Università, Viale Pieraccini, 17
Florence, Firenze, Italy
Ospedale Galliera
Genova, Genova, Italy
A.O. Ospedale S.Martino
Genova, GE, Italy
A.O. Carlo Poma - Via Albertoni, 1
Mantova, Mantova, Italy
A.O. Cà Granda, Piazza Ospedale Maggiore, 3
Milan, Milano, Italy
A.O. san Paolo
Milan, MI, Italy
Casa di Cura Igea
Milan, MI, Italy
Ospedale S.Carlo Borromeo
Milan, MI, Italy
A.O. S.Gerardo
Monza, MI, Italy
Policlinico di modena
Modena, Modena, Italy
Università Campus Biomedico, Via Emilio Longoni, 83
Roma, Roma, Italy
A.O. S.Giovanni Calabita Fatebenefratelli
Roma, Roma, Italy
Countries
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Central Contacts
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Other Identifiers
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2007-001781-32
Identifier Type: -
Identifier Source: org_study_id