Metastatic Advanced Pancreas Sorafenib (MAPS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Mario Negri Institute for Pharmacological Research
Information provided by:
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
ClinicalTrials.gov Identifier:
NCT00758381
First received: September 22, 2008
Last updated: October 9, 2008
Last verified: October 2008
  Purpose

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 Intervention Phase
Locally Advanced Pancreatic Cancer
Drug: Sorafenib 400 mg po bid, continuously
Drug: Gemcitabina, Cisplatino
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: time from randomization date to date of local or regional relapse ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 114
Study Start Date: August 2007
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

NEXAVAR*112CPR RIV 200MG

Titolare AIC:

BAYER SpA

Numero di AIC dell'IMP:

037154010

Other Names:
  • L01XE05 V
  • Sostanza attiva o descrizione del livello ATC selezionato
  • SORAFENIB TOSILATO
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:
  • GEMZAR*INFUS 1FL 1G POLV
  • Titolare AIC:
  • ELI LILLY ITALIA SpA
  • Numero di AIC dell'IMP:
  • 029452012
  • CISPLATINO TEVA*EV 50MG 100ML
  • TEVA PHARMA ITALIA Srl
  • 026543025

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00758381

Contacts
Contact: Stefano Cascinu, MProfessor +39 071 5964 ext 171 cascinu@yahoo.com
Contact: Silvia Rota, Data Manager +39 0331 490052 centrotrialgiscad@yahoo.it

Locations
Italy
A.O. Treviglio-Caravaggio, P.le Ospedale n1 Recruiting
Treviglio, Bergamo, Italy, 24047
Sub-Investigator: sandro Barni, MD         
Ospedale S.Orsola Fatebenefratelli Active, not recruiting
Brescia, BS, Italy, 15100
A.O. Ospedale S.Martino Recruiting
Genova, GE, Italy, 16132
Sub-Investigator: Alberto Sobrero, MD         
Ospedale S.Carlo Borromeo Not yet recruiting
Milano, MI, Italy, 20123
Sub-Investigator: Donata Tabiadon, MD         
A.O. san Paolo Recruiting
Milano, MI, Italy, 20100
Sub-Investigator: Paolo Foa, MD         
Casa di Cura Igea Not yet recruiting
Milano, MI, Italy, 20100
Sub-Investigator: Gianfranco Pancera, MD         
A.O. S.Gerardo Recruiting
Monza, MI, Italy, 20052
Sub-Investigator: Paolo Bidoli, MD         
A.O. Universitaria Ospedali Riuniti Umberto I Recruiting
Ancona, Italy, 60020
Principal Investigator: Stefano Cascinu, M.Pr         
Ospedali Riuniti, Largo Barozzi, 1 Recruiting
Bergamo, Italy, 24128
Principal Investigator: Roberto Labianca, MD         
A.O.Policlinico S.Orsola Malpighi Active, not recruiting
Bologna, Italy, 40138
A.O. Careggi-Università, Viale Pieraccini, 17 Recruiting
Firenze, Italy, 50139
Sub-Investigator: Francesco Di Costanzo, MD         
Ospedale Galliera Active, not recruiting
Genova, Italy, 16132
A.O. Carlo Poma - Via Albertoni, 1 Recruiting
Mantova, Italy, 46100
Sub-Investigator: Enrico Aitini, MD         
A.O. Cà Granda, Piazza Ospedale Maggiore, 3 Recruiting
Milano, Italy, 20162
Sub-Investigator: Salvatore Siena, MPr         
Policlinico di modena Active, not recruiting
Modena, Italy, 41100
Università Campus Biomedico, Via Emilio Longoni, 83 Active, not recruiting
Roma, Italy, 00155
A.O. S.Giovanni Calabita Fatebenefratelli Active, not recruiting
Roma, Italy, 00186
Sponsors and Collaborators
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Mario Negri Institute for Pharmacological Research
Investigators
Study Chair: Stefano Cascinu, M.Professor GISCAD Foundation
  More Information

No publications provided

Responsible Party: Stefano CASCINU, Medical Professor, Fondazione GISCAD
ClinicalTrials.gov Identifier: NCT00758381     History of Changes
Other Study ID Numbers: 2007-001781-32
Study First Received: September 22, 2008
Last Updated: October 9, 2008
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente:
pancreatic cancer
advanced or metastatic
sorafenib

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Sorafenib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014