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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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Information provided by: | Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente |
ClinicalTrials.gov Identifier: | NCT00536614 |
This is multicenter, open-label, randomized, phase II trial in patients with locally advanced or metastatic pancreatic cancer. Primary objective: objective response rate. Secondary objectives: safety, time to disease progression, median duration of response, time to treatment failure, overall survival time, correlation between bio-pathological characterization (EGFR, akt, MAPks) objective response and survival
Condition | Intervention | Phase |
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Pancreatic Cancer |
Genetic: cetuximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | A Randomized Phase II Study of Gemcitabine/Cisplatin With or Without Cetuximab to Evaluate the Efficacy in Patients With Locally Advanced or Metastatic EGFR-EGFR-Positive Pancreatic Cancer. SpaCe Trial |
Enrollment: | 86 |
Study Start Date: | May 2005 |
Study Completion Date: | September 2006 |
Arms | Assigned Interventions |
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A: No Intervention
arm A) gemcitabine/cisplatin in combination with Cetuximab arm B) gemcitabine/cisplatin alone
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Genetic: cetuximab
Cetuximab is an EGFR antibody inhibitor; it has been shown to increase the activity of gemcitabine (GEM) in advanced pancreatic cancer.
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During the last years, the esocrine pancreatic carcinoma presented a slow but constant increase of incidence.
Chemotherapy determined disappointing results. Gemcitabine determined a slight advantage in survival and clinical benefit in comparison with gemcitabine with cisplatin or oxaliplatin Elevated expression of EGFR or its ligand correlates with worse prognosis in a variety of human cancers including pancreatic cancer. Therefore, blockade of EGFR activity would provide a novel strategy for the treatment of cancer. Cetuximab (C225) is a human/murine chimeric monoclonal antibody directed to the EGFR binding site. In a preclinical setting, Cetuximab has demonstrated anticancer activity both in cell culture experiments and in "in vivo" tumor xenograft animal model Since the combination of gemcitabine and cisplatin seems to be the more effective treatment for advanced pancreatic cancer and Cetuximab may improve activity of this combination we designed this phase II randomised trial to assess the role of Cetuximab in combination with gemcitabine and cisplatin in pancreatic cancer.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy | |
A.O. Ospedale Umberto I - Università - Località Torretta | |
Ancona, Italy, 60020 | |
Ospedali Riuniti, Largo Barozzi, 1 | |
Bergamo, Italy, 24128 | |
Casa di Cura di Poliambulanza, Via Bissolati 57 | |
Brescia, Italy, 25100 | |
A.O. Careggi-Università, Viale Pieraccini, 17 | |
Firenze, Italy, 50139 | |
Azienda USL 6 - Viale Alfieri, 36 | |
Livorno, Italy, 57121 | |
A.O. Carlo Poma - Via Albertoni, 1 | |
Mantova, Italy, 46100 | |
A.O. Cà Granda, Piazza Ospedale Maggiore, 3 | |
Milano, Italy, 20162 | |
Università Campus Biomedico, Via Emilio Longoni, 83 | |
Roma, Italy, 00155 | |
Italy, Bergamo | |
A.O. Treviglio-Caravaggio, P.le Ospedale n1 | |
Treviglio, Bergamo, Italy, 24047 | |
Italy, Milano | |
Ospedale S.Gerardo, Via Donizetti, 106 | |
Monza, Milano, Italy, 20052 |
Study Chair: | Stefano Cascinu, MD | Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente |
Study ID Numbers: | 2004-004309-69 |
Study First Received: | September 27, 2007 |
Last Updated: | September 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00536614 History of Changes |
Health Authority: | Italy: The Italian Medicines Agency |
pancreatic cancer metastatic EGFR locally advanced pancreatic cancer |
Antimetabolites Anti-Infective Agents Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Cetuximab Endocrine System Diseases Immunosuppressive Agents Antiviral Agents Antibodies |
Digestive System Diseases Radiation-Sensitizing Agents Cisplatin Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Gemcitabine Endocrine Gland Neoplasms Immunoglobulins |
Antimetabolites Anti-Infective Agents Digestive System Neoplasms Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Cetuximab Endocrine System Diseases Enzyme Inhibitors |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Radiation-Sensitizing Agents Therapeutic Uses Pancreatic Diseases Gemcitabine Endocrine Gland Neoplasms |