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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. 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
Mario Negri Institute for Pharmacological Research
Information provided by:
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

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.

Condition or disease Intervention/treatment Phase
Locally Advanced Pancreatic Cancer Drug: Sorafenib 400 mg po bid, continuously Drug: Gemcitabina, Cisplatino Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: A

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


Titolare AIC:


Numero di AIC dell'IMP:


Other Names:
  • L01XE05 V
  • Sostanza attiva o descrizione del livello ATC selezionato

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
Other Names:
  • Titolare AIC:
  • Numero di AIC dell'IMP:
  • 029452012
  • 026543025

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: time from randomization date to date of local or regional relapse ]

Secondary Outcome Measures :
  1. - 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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).

Information from the National Library of Medicine

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 identifier (NCT number): NCT00758381

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Contact: Stefano Cascinu, MProfessor +39 071 5964 ext 171
Contact: Silvia Rota, Data Manager +39 0331 490052

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Sponsors and Collaborators
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Mario Negri Institute for Pharmacological Research
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Study Chair: Stefano Cascinu, M.Professor GISCAD Foundation
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Responsible Party: Stefano CASCINU, Medical Professor, Fondazione GISCAD Identifier: NCT00758381    
Other Study ID Numbers: 2007-001781-32
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: October 10, 2008
Last Verified: October 2008
Keywords provided by Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente:
pancreatic cancer
advanced or metastatic
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action