metastatic colo-rectal tumor MedDRA version: 9.1 Level: LLT Classification code 10050035 Term: Metastatic colon cancer
Conditions
Sponsors
AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age between 18 and 75 Adenocarcinoma colon histologically confirmed independently dall'EGFR Patients with the disease locally advanced or metastatic undergone previous chemotherapy line with t Irinotecan and progression of disease after this treatment Waiting for lives of at least 12 weeks Performance Status (WHO performance status): 0 or 1 Informed written, signed, obtained before any specific procedure for screening of the study Use of contraceptive measures effective in patients at risk of pregnancy. ANC >1.5 x 109/L e PLATELETS >100 x 109/L total BILIRUBINE=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Medical history pathological positive for malignancies, except: carcinoma in situ of the cervix, or basal cell carcinoma squamous adequately treated and past malignancy with a time free of disease> 5 years and no signs or symptoms of relapse, excluding However, past patients with breast cancer and melanoma Pregressa exposure to EGF, for monoclonal antibodies, for inhibitors signal translation, or therapy having target the EGFR Clinically significant coronary artery disease or history of heart attack myocardial in the last 12 months Inflammatory bowel disease Brain metastases Women members who are pregnant or breastfeeding Known hypersensitivity reaction against any of the components of the treatment being studied.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessing in patients with metastatic colorectal cancer refractory to treatment with chemotherapy and Irinotecan 5FU the correlation between the response to treatment with Cetuximab in combination with chemotherapy based Irinotecan; search for mutations of K-RAS and odetermination of PTEN by immunohistochemistry; Gene amplification dell'EGFR determined by FISH; the intensity of expression dell'EGFR determined by immunohistochemistry test with DAKO and Zymed (monoclonal antibody clone 31G7);Secondary Objective: assessing time to progressio incidence of brain methastasis rate of ri-conversion to surgery of mts liver as only site of illness assesment of toxicity assessmento of overall survival and diseas free survival;Primary end point(s): Assessing in patients with metastatic colorectal cancer refractory to treatment with chemotherapy and Irinotecan 5FU the correlation between the response to treatment with Cetuximab in combination with chemotherapy based Irinotecan; search for mutations of K-RAS and odetermination of PTEN by immunohistochemistry; Gene amplification dell'EGFR determined by FISH; the intensity of expression dell'EGFR determined by immunohistochemistry test with DAKO and Zymed (monoclonal antibody clone 31G7) | — |
Countries
Italy
Outcome results
None listed