Advanced or metastatic gastric and gastroesophageal junction adenocarcinoma MedDRA version: 9.1 Level: LLT Classification code 10056267 Term: Gastroesophageal cancer
Conditions
Interventions
Trade Name: ERBITUX*INFUS 1FL 50ML 2MG/ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CETUXIMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Signed written informed consent ? Male or female >= 18 years of age ? Diagnosis of histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (biopsy or surgical specimen) ? Locally advanced or metastatic gastric and gastro-esophageal junction cancer ? Presence of at least one bi-dimensional indicator lesion measurable by CT scan or MRI in not an irradiated area ? Life expectancy of > 3 months ? Karnofsky performance status of >= 70 at study entry ? Laboratory data: - Neutrophils >= 1.5 x 109/L, platelets >= 100 x 109/L, hemoglobin >= 9 g/dl - ALAT and ASAT =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Brain metastasis ? Previous chemotherapy for metastatic gastric or gastroesophageal junction 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) within 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 meaninful informed consent ? Women who are pregnant or breastfeeding ? Acute or subacute intestinal occlusion ? 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ?To investigate the efficacy and safety of Cetuximab in combination with Docetaxel plus Cisplatin in patients with locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma , not previously treated with chemotherapy.;Secondary Objective: appraisal of the toxicity, of the time to the progression, the survival and the correlation between bio-pathological factors (p53, bcl-2, ki-67, EGFR, TS)and objective response/survival;Primary end point(s): ?Confirmed response rate of Cetuximab in combination with Docetaxel plus Cisplatin in patients with locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma | — |
Countries
Italy
Outcome results
None listed