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
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.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival
A subject's survival time will be defined as the time from randomization to the date of his or her death. If the subject has not died, survival will be censored on last date the subject was known to be alive.
Stefano Cascinu, MD
Study Chair
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Italy: The Italian Medicines Agency
2004-004309-69
NCT00536614
May 2005
September 2006
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