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

September 27, 2007 updated by: Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

86

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy, 60020
        • A.O. Ospedale Umberto I - Università - Località Torretta
      • Bergamo, Italy, 24128
        • Ospedali Riuniti, Largo Barozzi, 1
      • Brescia, Italy, 25100
        • Casa di Cura di Poliambulanza, Via Bissolati 57
      • Firenze, Italy, 50139
        • A.O. Careggi-Università, Viale Pieraccini, 17
      • Livorno, Italy, 57121
        • Azienda USL 6 - Viale Alfieri, 36
      • Mantova, Italy, 46100
        • A.O. Carlo Poma - Via Albertoni, 1
      • Milano, Italy, 20162
        • A.O. Cà Granda, Piazza Ospedale Maggiore, 3
      • Roma, Italy, 00155
        • Università Campus Biomedico, Via Emilio Longoni, 83
    • Bergamo
      • Treviglio, Bergamo, Italy, 24047
        • A.O. Treviglio-Caravaggio, P.le Ospedale n1
    • Milano
      • Monza, Milano, Italy, 20052
        • Ospedale S.Gerardo, Via Donizetti, 106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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

Outcome Measure
Time Frame
response to treatment, and toxicity
Time Frame: the time from randomization until the date of discontinuation of treatment or progression or death
the time from randomization until the date of discontinuation of treatment or progression or death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

Collaborators

Mario Negri Institute for Pharmacological Research

Investigators

  • Study Chair: Stefano Cascinu, MD, Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Study Completion (ACTUAL)

September 1, 2006

Study Registration Dates

First Submitted

September 27, 2007

First Submitted That Met QC Criteria

September 27, 2007

First Posted (ESTIMATE)

September 28, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

September 28, 2007

Last Update Submitted That Met QC Criteria

September 27, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004-004309-69

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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