Gemcitabine/Cisplatin +/-Cetuximab in Patients With Locally Advanced or Metastatic EGFR-Positive Pancreatic Cancer (SPaCe-01)

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: NCT00536614
Recruitment Status : Completed
First Posted : September 28, 2007
Last Update Posted : September 28, 2007
Mario Negri Institute for Pharmacological Research
Information provided by:
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

Brief Summary:
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 or disease Intervention/treatment Phase
Pancreatic Cancer Genetic: cetuximab Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 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 Cetuximab to Evaluate the Efficacy in Patients With Locally Advanced or Metastatic EGFR-EGFR-Positive Pancreatic Cancer. SpaCe Trial
Study Start Date : May 2005
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: A
arm A) gemcitabine/cisplatin in combination with Cetuximab arm B) gemcitabine/cisplatin alone
Genetic: cetuximab
Cetuximab is an EGFR antibody inhibitor; it has been shown to increase the activity of gemcitabine (GEM) in advanced pancreatic cancer.

Primary Outcome Measures :
  1. Overall survival [ Time Frame: 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. ]

Secondary Outcome Measures :
  1. response to treatment, and toxicity [ Time Frame: the time from randomization until the date of discontinuation of treatment or progression or death ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Age ≥ 18 years
  • Histologically confirmed diagnosis of 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)
  • Immunohistochemical evidence or positive EGFR expression prior to study entry in primary tumor and/or at least one metastasis
  • Life expectancy of ≥ 3 months
  • 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
  • Effective contraception for both, male and female patients if the risk of conception exists
  • Signed written informed consents prior to beginning protocol specific procedures

Exclusion Criteria:

  • Brain metastasis
  • Previous chemotherapy for locally advanced or metastatic pancreatic cancer
  • Adjuvant therapy is allowed if recurrence is documented > 6 months after the end of adjuvant treatment
  • Radiotherapy within 4 weeks prior to study entry
  • Concurrent chronic systemic immune therapy
  • Any investigational agent(s) 4 weeks prior to entry
  • Previous exposure to EGF, monoclonal antibodies, signal transduction inhibitors or EGFR targeting therapy
  • Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months
  • 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
  • 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): NCT00536614

A.O. Treviglio-Caravaggio, P.le Ospedale n1
Treviglio, Bergamo, Italy, 24047
Ospedale S.Gerardo, Via Donizetti, 106
Monza, Milano, Italy, 20052
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
Sponsors and Collaborators
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Mario Negri Institute for Pharmacological Research
Study Chair: Stefano Cascinu, MD Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00536614     History of Changes
Other Study ID Numbers: 2004-004309-69
First Posted: September 28, 2007    Key Record Dates
Last Update Posted: September 28, 2007
Last Verified: September 2007

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

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs