Gemcitabine/Cisplatin +/-Cetuximab in Patients With Locally Advanced or Metastatic EGFR-Positive Pancreatic Cancer
NCT ID: NCT00536614
Last Updated: 2007-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
86 participants
INTERVENTIONAL
2005-05-31
2006-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
arm A) gemcitabine/cisplatin in combination with Cetuximab arm B) gemcitabine/cisplatin alone
cetuximab
Cetuximab is an EGFR antibody inhibitor; it has been shown to increase the activity of gemcitabine (GEM) in advanced pancreatic cancer.
Interventions
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cetuximab
Cetuximab is an EGFR antibody inhibitor; it has been shown to increase the activity of gemcitabine (GEM) in advanced pancreatic cancer.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Mario Negri Institute for Pharmacological Research
OTHER
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
OTHER
Principal Investigators
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Stefano Cascinu, MD
Role: STUDY_CHAIR
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Locations
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A.O. Ospedale Umberto I - Università - Località Torretta
Ancona, Ancona, Italy
Ospedali Riuniti, Largo Barozzi, 1
Bergamo, Bergamo, Italy
A.O. Treviglio-Caravaggio, P.le Ospedale n1
Treviglio, Bergamo, Italy
Casa di Cura di Poliambulanza, Via Bissolati 57
Brescia, Brescia, Italy
A.O. Careggi-Università, Viale Pieraccini, 17
Florence, Firenze, Italy
Azienda USL 6 - Viale Alfieri, 36
Livorno, Livorno, Italy
A.O. Carlo Poma - Via Albertoni, 1
Mantova, Mantova, Italy
A.O. Cà Granda, Piazza Ospedale Maggiore, 3
Milan, Milano, Italy
Ospedale S.Gerardo, Via Donizetti, 106
Monza, Milano, Italy
Università Campus Biomedico, Via Emilio Longoni, 83
Roma, Roma, Italy
Countries
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References
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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.
Other Identifiers
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2004-004309-69
Identifier Type: -
Identifier Source: org_study_id