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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
cetuximab
Sponsored by
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreatic cancer, metastatic, EGFR, locally advanced pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • A.O. Treviglio-Caravaggio, P.le Ospedale n1
  • Ospedale S.Gerardo, Via Donizetti, 106
  • A.O. Ospedale Umberto I - Università - Località Torretta
  • Ospedali Riuniti, Largo Barozzi, 1
  • Casa di Cura di Poliambulanza, Via Bissolati 57
  • A.O. Careggi-Università, Viale Pieraccini, 17
  • Azienda USL 6 - Viale Alfieri, 36
  • A.O. Carlo Poma - Via Albertoni, 1
  • A.O. Cà Granda, Piazza Ospedale Maggiore, 3
  • Università Campus Biomedico, Via Emilio Longoni, 83

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

A

Arm Description

arm A) gemcitabine/cisplatin in combination with Cetuximab arm B) gemcitabine/cisplatin alone

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

response to treatment, and toxicity

Full Information

First Posted
September 27, 2007
Last Updated
September 27, 2007
Sponsor
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Collaborators
Mario Negri Institute for Pharmacological Research
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1. Study Identification

Unique Protocol Identification Number
NCT00536614
Brief Title
Gemcitabine/Cisplatin +/-Cetuximab in Patients With Locally Advanced or Metastatic EGFR-Positive Pancreatic Cancer
Acronym
SPaCe-01
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 Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Collaborators
Mario Negri Institute for Pharmacological Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
pancreatic cancer, metastatic, EGFR, locally advanced pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
No Intervention
Arm Description
arm A) gemcitabine/cisplatin in combination with Cetuximab arm B) gemcitabine/cisplatin alone
Intervention Type
Genetic
Intervention Name(s)
cetuximab
Intervention Description
Cetuximab is an EGFR antibody inhibitor; it has been shown to increase the activity of gemcitabine (GEM) in advanced pancreatic cancer.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
response to treatment, and toxicity
Time Frame
the time from randomization until the date of discontinuation of treatment or progression or death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Cascinu, MD
Organizational Affiliation
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Official's Role
Study Chair
Facility Information:
Facility Name
A.O. Treviglio-Caravaggio, P.le Ospedale n1
City
Treviglio
State/Province
Bergamo
ZIP/Postal Code
24047
Country
Italy
Facility Name
Ospedale S.Gerardo, Via Donizetti, 106
City
Monza
State/Province
Milano
ZIP/Postal Code
20052
Country
Italy
Facility Name
A.O. Ospedale Umberto I - Università - Località Torretta
City
Ancona
ZIP/Postal Code
60020
Country
Italy
Facility Name
Ospedali Riuniti, Largo Barozzi, 1
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
Facility Name
Casa di Cura di Poliambulanza, Via Bissolati 57
City
Brescia
ZIP/Postal Code
25100
Country
Italy
Facility Name
A.O. Careggi-Università, Viale Pieraccini, 17
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Azienda USL 6 - Viale Alfieri, 36
City
Livorno
ZIP/Postal Code
57121
Country
Italy
Facility Name
A.O. Carlo Poma - Via Albertoni, 1
City
Mantova
ZIP/Postal Code
46100
Country
Italy
Facility Name
A.O. Cà Granda, Piazza Ospedale Maggiore, 3
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Università Campus Biomedico, Via Emilio Longoni, 83
City
Roma
ZIP/Postal Code
00155
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
18077217
Citation
Cascinu S, Berardi R, Labianca R, Siena S, Falcone A, Aitini E, Barni S, Di Costanzo F, Dapretto E, Tonini G, Pierantoni C, Artale S, Rota S, Floriani I, Scartozzi M, Zaniboni A; Italian Group for the Study of Digestive Tract Cancer (GISCAD). Cetuximab plus gemcitabine and cisplatin compared with gemcitabine and cisplatin alone in patients with advanced pancreatic cancer: a randomised, multicentre, phase II trial. Lancet Oncol. 2008 Jan;9(1):39-44. doi: 10.1016/S1470-2045(07)70383-2.
Results Reference
derived

Learn more about this trial

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

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