E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
metastatic colo-rectal tumor |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050035 |
E.1.2 | Term | Metastatic colon cancer |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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) |
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E.2.2 | Secondary objectives of the trial |
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 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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< 1.5 of upper normal limit (LSN) of range and AST (SGOT) e/o ALT (SGPT) <2.5 x LSN, o <5 x LSN in case of liver methastasis fosf atasii alcalina <2.5 x UNL, <5 x LSN in case of liver metastasis <10 x LSN in case of bone metastasis |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |